Post on 02-Nov-2021
ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 15- avobenzone, octisalate,octocrylene lotion Fischer Pharmaceuticals LtdDisclaimer: 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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Dr. Fischer ULTRASOL Sunscreen Lotion SPF15
Dr. Fischer ULTRASOL
Sunscreen Lotion
SPF 15
Broad Spectrum UVA and UVB Protection
Dermatologist Recommended
SCIENCE INSIDE - SUPERIOR SUN TECHNOLOGY
VERY WATER RESISTANT
Hypoallergenic
Sensitive Approved
RECOMMENDED SKIN CANCER FOUNDATION
250 ML. 8.45 FL. OZ.
FISCHER PHARMACEUTICALS
(Back of Package):
Manufactured by:
Fischer Pharmaceuticals Ltd.
Bnei Brak, Israel, 51553
Made in Israel
www.dr-fischer.com
NO ANIMAL INGREDIENTS - NO ANIMAL TESTING
24m
Dr. Fischer - Tried and Tested
Drug FactsActive Ingredients PurposeAvobenzone 2.0%, Octocrylene 7.0%, Octisalate 5.0% ....... Sunscreen
Uses• helps prevent sunburn • higher SPF gives more sunburn protection• helps protect the skin against the harmful effects of UVA and UVB rays• retains SPF after 80 minutes of activity in the water or sweating
WarningsFor external use only
When us ing this productavoid contact with the eyes. If contact occurs rinsethoroughly with water.
Stop use and ask a doctor ifrash or irritation develops and lasts.
Keep out of reach of children.
TM
If swallowed, get medical help or contact a PoisonControl Center immediately.
Directions• apply generously and evenly to all exposed areas before sun exposure• reapply as needed or after towel drying, swimming, perspiring or vigorous activity• children under 6 months of age: ask a doctor
Other Information• may stain some fabrics• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreensmay reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Inactive IngredientsAcrylates / C10-30 Alkyl Acrylate Crosspolymer,Butylparaben, Chlorophenesin, Disodium EDTA, Ethylparaben, Fragrance, GlycerylStearate, Green Tea (Camellia Sinensis) Leaf Extract, Iodopropynyl Butylcarbamate,Isopropyl Myristate, Methylparaben, Phenoxyethanol, Polyethylene, Potassium CetylPhosphate, Propylene Glycol, Propylparaben, Sodium Hydroxide, Stearic Acid, StearylAlcohol, Tocopheryl Acetate, Water.
Questions or Comments?Call 1-877-212-1985 Mon-Fri
ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 15 avobenzone, octisalate, octocrylene lotion
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:59 8 8 6 -318
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
Avo benzo ne (UNII: G6 3QQF2NOX) (Avo benzo ne - UNII:G6 3QQF2NOX) Avo benzo ne 2 g in 10 0 g
O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM) Octo crylene 7 g in 10 0 g
O ctisa la te (UNII: 4X49 Y0 59 6 W) (Octisa la te - UNII:4X49 Y0 59 6 W) Octisa la te 5 g in 10 0 g
Inactive IngredientsIngredient Name Strength
Butylpa ra ben (UNII: 3QPI1U3FV8 )
Chlo rphenesin (UNII: I6 70 DAL4SZ)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
Ethylpa ra ben (UNII: 14255EXE39 )
Fischer Pharmaceuticals Ltd
GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)
Iso pro pyl Myrista te (UNII: 0 RE8 K4LNJS)
Methylpa ra ben (UNII: A2I8 C7HI9 T)
Pheno xyetha no l (UNII: HIE49 2ZZ3T)
Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)
Pro pylpa ra ben (UNII: Z8 IX2SC1OH)
So dium Hydro xide (UNII: 55X0 4QC32I)
Stea ric Acid (UNII: 4ELV7Z6 5AP)
Stea ryl Alco ho l (UNII: 2KR8 9 I4H1Y)
ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
Wa ter (UNII: 0 59 QF0 KO0 R)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:59 8 8 6 -318 -55 250 g in 1 BOTTLE, PLASTIC
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part352 0 3/0 1/20 10
Labeler - Fischer Pharmaceuticals Ltd (600158976)
EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations
Fischer Pharmaceutica ls Ltd 6 0 0 158 9 76 manufacture
Revised: 1/2010