ACNE ADVANCED TREATMENT SYSTEM- salicylic acid Eminence Organic Skin Care Ltd.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Acne Advanced Treatment Sys tem

Drug Facts

Active ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

UseFor the treatment of acne.

Warnings

For external use only

When us ing this productSkin irritation and dryness are more likely to occur when using another topical acne product at thesame time. If irritation occurs, use only one product at a time.Avoid eye area. In case of eye contact, flush gently and thoroughly with water.

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.

DirecitonsUse 1 to 3 times daily.Pump a small amount of product to transform the liquid into a lightweight foam. Apply to skin andmassage gently with fingertips in a circular motion covering the face and neck. Rinse thoroughly andpat dry.Because excessive drying of the skin may occur, strar with one application daily, then graduallyincrease to 2 ot 3 times daily if needed or as directed by a doctor. if bothersome dryness or peelingoccurs, reduce application to once a day or every other day.

Other information

Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightlyclosed.

Inactive ingredients

Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix

Alba (Willow) Bark Extract, Rosa Canina (Rosehip) Seed Extract, Citrus Paradisi (Grapefruit) PeelExtract, Symphytum Officinale (Comfrey) Leaf Extract, Lavandula Angustifolia (Lavender) FlowerExtract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract,Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glyceri], DecylGlucoside, Sodium Cocoyl Glutamate, Citrus Grandis (Grapefruit) Peel Oil, Metha Spicata (Spearmint)Leaf Oil, Caprylyl Glycol, Tocopherol (Vitamin E), Panthenol (Provitamin B5), Thymus Vulgans(Thyme) Extract, Cinnamomum Zeylanicum (Cinnamon) Bark Extract, Ole Europaea (Olive) Leaf Extract,Rosmarinus Officinalis (Rosemary) Leaf Extract, Cocamidopropyl Dimethylamine, Mentha Piperita(Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hydrastis Canadensis(Goldenseal) Root Extract, Citrus Limon (Lemon) Peel Extract, Ethylhexylglycerin, Caffeine (fromGreen Tea), Sodium PCA, Arbutin, Biocomplex2 [Euterpe Oleracea (Acai), Citrus Limon (Lemon),Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata(Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut)Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (AlphaLipoic Acid) and Ubiquinone (Coenzyme Q10), Vegetable Glycerin. *Certified organic ingredient

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

UseFor the treatment of acne.

Warnings

For external use only

When us ing this productSkin irritation and dryness are more likely to occur when using another topical acne product at thesame time. if irritation occurs, use only one product at a time.Avoid eye area. In case of eye contact, flush gently and thoroughly with water.

Keep out of reach of children.If swallowed, get medical help or contaact Poison Control Center right away.

DirecitonsCleanse skin thoroughly before applying this productApply a small amount evenly over the entire face or as a spot treatment as desired.Allow to dry for 5 to 10 minutes.Rinse thoroughly with lukewarm water and use a face cloth if desired.Use weekly as a masque, or as a spot treatment up to 3 times per day. Because excessive drying ofthe skin may occur, start with one application daily, then gradually increase to 2 ot 3 times daily ifneeded or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application toonce a day or every other day.

Other information

Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightlyclosed. Do not use if seal under cap is broken or missing.

Inactive ingredients

Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, SalixAlba (Willow) Bark Extract, Rosa Canina (Rosehip) Seed Extract, Citrus Paradisi (Grapefruit) PeelExtract, Symphytum Officinale (Comfrey) Leaf Extract, Lavandula Angustifolia (Lavender) FlowerExtract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract,Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glycerin], KaolinClay, Red Kaolin Clay, Vegetable Glycerin, Glycine Soja Soybean) Oil, Benzyl Alcohol, HelianthusAnnuus (Sunflower Seed) Oil, Sorbic Acid, Polyacrylate 13, Citrus Grandis (Grapefruit) Peel Oil,Metha Spicata (Spearmint) Leaf Oil, Polysobutene, Cocamidopropyl Dimethylamine, Sulfur, OcimumBasillicum (Basil) Oil, Lavandula Angustifolia (Lavender) Flower Extract, Tocopheryl Acetate(Vitamin E), Xanthan Gum, Montmorillonite Caly, Sodium PCA, Polysorbate 20, Eucalyptus Globulus(Eucalyptus) Oil, Retinyl Palmitate (Vitamin A), Usnea Barbata (Lichen) Extract, Biocomplex2 [EuterpeOleracea (Acai), [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (BarbadosCherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (CamuCamu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji)Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone(Coenzyme Q10)

*Certified organic ingredient

Drug Facts

Active ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

UseFor the treatment of acne.

Warnings

For external use only

When us ing this productSkin irritation and dryness are more likely to occur when using another topical acne product at thesame time. if irritation occurs, use only one product at a time.avoid eye area. In case of eye contact, flush gently and thoroughly with water.

Keep out of reach of children.If swallowed, get medical help or contaact Poison Control Center right away.

Direcitons

Cleanse skin thoroughly before applying this productApply a layer over the entire face and neck 1 to 3 times daily and leave on.Because excessive drying of the skin may occur, start with one application daily, then graduallyincrease to 2 ot 3 times daily if needed or as directed by a doctor. If bothersome dryness or peelingoccurs, reduce application to once a day or every other day.

Other information

Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightlyclosed.

Inactive ingredients

Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, SalixAlba (Willow) Bark Extract, Rosa Canina (Rosehip) Seed Extract, Citrus Paradisi (Grapefruit) PeelExtract, Symphytum Officinale (Comfrey) Leaf Extract, Lavandula Angustifolia (Lavender) FlowerExtract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract,Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glycerin],Caprylic/Capric Triglyceride, Hamamelis Virginiana (Witch Hazel), Vegetable Glycerin, Propanediol,Citrus Grandis (Grapefruit) Peel Oil, Mentha Spicata (Spearmint) Leaf Oil, Sodium Acrylate, NyphaeaCaerulea (Blue Lotus) Flower Extract, Nelumbo Nucifera (Sacred Lotus) Flower Extract, OriganumVulgare (Oregano) Leaf Extract, Thymus Vulgaris (Thyme) Extract, Cinnamomum Zeylanium(Cinnamon) Bark Extract, Olea Europaea (Olive) Leaf Extract, Rosmarinus Officinalis (Rosemary) LeafExtract, Sodium Starch Octenylsuccinate, Mentha Piperita (Peppermint) Leaf Extract, LavandulaAngustifolia (Lavender) Flower Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Citrus Limon(Lemon) Peel Extract, Sodium Acrylolydimethyl Taurate Copolymer, Panthenol (Provitamin B5),Sodium Hydroxide, Isohexadecane, Niacinamide (Vitamin B3), Acrylates/C12-22 Alkyl MethacrylateCopolymer, Allantoin, Polysorbate 80, Lysolecithin, Caffeine (from Green Tea), Zinc Hyaluronate,Arbutin, Cocamidopropyl Dimethylamine, Biocomplex2 [Euterpe Oleracea (Acai), [Euterpe Oleracea(Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (IndianGooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa(Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (fromCassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)

*Certified organic ingredient

Acne Advanced Cleans ing Foam 5oz (15751-3010-5)

Acne Advanced Clarifying Masque 2oz (15751-3020-2)

Acne Advanced Clarifying Hydrator 1.2oz (15751-3030-2)

Kit: Acne Advanced Treatment Sys tem (15751-3000-3)

ACNE ADVANCED TREATMENT SYSTEM salicylic acid kit

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:15751-30 0 0

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:15751-30 0 0 -3 1 in 1 KIT 0 9 /0 1/20 18

Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 1 BOTTLE 150 mL

Pa rt 2 1 TUBE 6 0 mL

Pa rt 3 1 BOTTLE 35 mL

Part 1 of 3

ACNE ADVANCED CLEANSING salicylic acid liquid

Product InformationIte m Code (Source ) NDC:15751-30 10

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 10 mg in 1 mL

Inactive IngredientsIngredient Name Strength

ALO E (UNII: V5VD430 YW9 )

CUCUMBER (UNII: YY7C30 VXJT)

RO SA MO SCHATA O IL (UNII: J9 9 W255AWF)

GRAPEFRUIT (UNII: O8 2C39 RR8 C)

SYMPHYTUM UPLANDICUM LEAF (UNII: D0 5HXK6 R3G)

PEPPERMINT (UNII: V9 5R5KMY2B)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

BETA VULGARIS (UNII: 4G174V50 51)

GLYCERIN (UNII: PDC6 A3C0 OX)

DECYL GLUCO SIDE (UNII: Z17H9 7EA6 Y)

SO DIUM CO CO YL GLUTAMATE (UNII: BMT4RCZ3HG)

SPEARMINT (UNII: J7I2T6 IV1N)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

DEXPANTHENO L (UNII: 1O6 C9 3RI7Z)

THYME (UNII: CW6 57OBU4N)

CINNAMO N (UNII: 5S29 HWU6 QB)

O LIVE O IL (UNII: 6 UYK2W1W1E)

RO SEMARY (UNII: IJ6 7X351P9 )

CO CAMIDO PRO PYL DIMETHYLAMINE (UNII: L36 BM7DG2T)

GO LDENSEAL (UNII: ZW3Z11D0 JV)

LEMO N (UNII: 24RS0 A9 8 8 O)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

ARBUTIN (UNII: C5INA23HXF)

ACAI (UNII: 46 AM2VJ0 AW)

CARRO T (UNII: L56 Z1JK48 B)

CO CO NUT (UNII: 3RT3536 DHY)

STARCH, TAPIO CA (UNII: 24SC3U70 4I)

THIO CTIC ACID (UNII: 73Y7P0 K73Y)

UBIDECARENO NE (UNII: EJ27X76 M46 )

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:15751-30 10 -5 1 in 1 BOX

1 150 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part333D 0 9 /0 1/20 18

Part 2 of 3

ACNE ADVANCED CLARIFYING MASQUE salicylic acid cream

Product InformationIte m Code (Source ) NDC:15751-30 20

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg in 1 mL

Inactive IngredientsIngredient Name Strength

ALO E (UNII: V5VD430 YW9 )

CUCUMBER (UNII: YY7C30 VXJT)

RO SA MO SCHATA O IL (UNII: J9 9 W255AWF)

GRAPEFRUIT (UNII: O8 2C39 RR8 C)

SYMPHYTUM UPLANDICUM LEAF (UNII: D0 5HXK6 R3G)

PEPPERMINT (UNII: V9 5R5KMY2B)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

BETA VULGARIS (UNII: 4G174V50 51)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO YBEAN O IL (UNII: 241ATL177A)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

SO DIUM PO LYACRYLATE ( 2 50 0 0 0 0 MW) (UNII: 0 5I15JNI2J)

SPEARMINT (UNII: J7I2T6 IV1N)

CO CAMIDO PRO PYL DIMETHYLAMINE (UNII: L36 BM7DG2T)

SULFUR (UNII: 70 FD1KFU70 )

BASIL O IL (UNII: Z129 UMU8 LE)

XANTHAN GUM (UNII: TTV12P4NEE)

MO NTMO RILLO NITE (UNII: A58 5MN1H2L)

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

ACAI (UNII: 46 AM2VJ0 AW)

CARRO T (UNII: L56 Z1JK48 B)

CO CO NUT (UNII: 3RT3536 DHY)

STARCH, TAPIO CA (UNII: 24SC3U70 4I)

THIO CTIC ACID (UNII: 73Y7P0 K73Y)

UBIDECARENO NE (UNII: EJ27X76 M46 )

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:15751-30 20 -2 1 in 1 BOX

1 6 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part333D 0 9 /0 1/20 18

Part 3 of 3

ACNE ADVANCED CLARIFYING HYDRATOR salicylic acid cream

Product InformationIte m Code (Source ) NDC:15751-30 30

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 10 mg in 1 mL

Inactive IngredientsIngredient Name Strength

ALO E (UNII: V5VD430 YW9 )

CUCUMBER (UNII: YY7C30 VXJT)

RO SA MO SCHATA O IL (UNII: J9 9 W255AWF)

GRAPEFRUIT (UNII: O8 2C39 RR8 C)

SYMPHYTUM UPLANDICUM LEAF (UNII: D0 5HXK6 R3G)

PEPPERMINT (UNII: V9 5R5KMY2B)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

BETA VULGARIS (UNII: 4G174V50 51)

GLYCERIN (UNII: PDC6 A3C0 OX)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

HAMAMELIS VIRGINIANA RO O T BARK/STEM BARK (UNII: T7S323PKJS)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

CITRUS MAXIMA FRUIT RIND O IL (UNII: 8 U38 77WD44)

SPEARMINT (UNII: J7I2T6 IV1N)

SO DIUM ACRYLATE (UNII: 7C9 8 FKB43H)

O REGANO (UNII: 0 E5AT8 T16 U)

THYME (UNII: CW6 57OBU4N)

CINNAMO N (UNII: 5S29 HWU6 QB)

O LIVE O IL (UNII: 6 UYK2W1W1E)

RO SEMARY (UNII: IJ6 7X351P9 )

GO LDENSEAL (UNII: ZW3Z11D0 JV)

LEMO N (UNII: 24RS0 A9 8 8 O)

DEXPANTHENO L (UNII: 1O6 C9 3RI7Z)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

NIACIN (UNII: 26 79 MF6 8 7A)

ALLANTO IN (UNII: 344S277G0 Z)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

LYSO PHO SPHATIDYLCHO LINE, SO YBEAN (UNII: CQD8 3320 4Z)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

ARBUTIN (UNII: C5INA23HXF)

CO CAMIDO PRO PYL DIMETHYLAMINE (UNII: L36 BM7DG2T)

SO YBEAN O IL (UNII: 241ATL177A)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

SO DIUM PO LYACRYLATE ( 2 50 0 0 0 0 MW) (UNII: 0 5I15JNI2J)

ACAI (UNII: 46 AM2VJ0 AW)

CARRO T (UNII: L56 Z1JK48 B)

CO CO NUT (UNII: 3RT3536 DHY)

STARCH, TAPIO CA (UNII: 24SC3U70 4I)

THIO CTIC ACID (UNII: 73Y7P0 K73Y)

Eminence Organic Skin Care Ltd.

UBIDECARENO NE (UNII: EJ27X76 M46 )

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:15751-30 30 -2 1 in 1 BOX

1 35 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part333D 0 9 /0 1/20 18

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part333D 0 9 /0 1/20 18

Labeler - Eminence Organic Skin Care Ltd. (205753317)

Revised: 11/2018