Label: SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 41520-940-34
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 6, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
■ apply liberally {and evenly} 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ 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-sleeved shirts, pants, hats and sunglasses
■ children under 6 months of age: Ask a doctor - Other information
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Inactive ingredients
water, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, fragrance, benzyl alcohol, disodium EDTA
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SPL UNCLASSIFIED SECTION
May stain or damage some fabrics or surfaces
Dist by Foolhold USA, LLC
Landover, MD 20785 1-877-848-8949
(c) S&S Brands, LLC
Quality guraranteed or your money back.
*This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 50.
*Oxybenzone & Octinoxate Free
- Principal Panel Display
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INGREDIENTS AND APPEARANCE
SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-940 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) POLYESTER-7 (UNII: 0841698D2F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) YELLOW WAX (UNII: 2ZA36H0S2V) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) DOCOSANOL (UNII: 9G1OE216XY) TOCOPHEROL (UNII: R0ZB2556P8) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-940-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/08/2019 Labeler - American Sales Company (809183973) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(41520-940)
