Label: COPPERTONE WATERBABIES PURE AND SIMPLE SUNSCREEN SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion
- NDC Code(s): 66800-4839-5
- Packager: Beiersdorf Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 7, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Use
- Warnings
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Directions
■ apply liberally 15 minutes before sun exposure
■ reapply:
■ after 80 minutes of swimming or sweating
■ immediately after towel drying
■ at least every 2 hours
■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
■ limit time in the sun, especially from 10 a.m. – 2 p.m.
■ wear long-sleeve shirts, pants, hats, and sunglasses
■ children under 6 months: Ask a doctor
- Other information
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Inactive ingredients
water, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice,
tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide,
disodium EDTA, sodium ascorbyl phosphate
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INGREDIENTS AND APPEARANCE
COPPERTONE WATERBABIES PURE AND SIMPLE SUNSCREEN SPF 50
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4839 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) WATER (UNII: 059QF0KO0R) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) ALOE VERA LEAF (UNII: ZY81Z83H0X) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Product Characteristics Color white (White to Off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-4839-5 177 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/29/2021 Labeler - Beiersdorf Inc (001177906)
