Label: COVER ME SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-280-01 - Packager: Jafra Cosmetics International
- Category: HUMAN OTC DRUG LABEL
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 June 11, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: Ask a doctor
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
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INACTIVE INGREDIENT
Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia sinensis Leaf Extract, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, PEG-100 Stearate, PEG-40 Hydrogenated Castor Oil, Phenethyl Alcohol, Phenoxyethanol, Royal Jelly Powder, Royal Jelly, Silica, Styrene/Acrylates Copolymer, Tetrapeptide-45, Trideceth-9, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Zingiber Officinale (Ginger) Root Extract. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COVER ME SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-280 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) SHEA BUTTER (UNII: K49155WL9Y) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIPROPYLENE GLYCOL (UNII: E107L85C40) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LEVOMENOL (UNII: 24WE03BX2T) ARGININE (UNII: 94ZLA3W45F) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) ROYAL JELLY (UNII: L497I37F0C) TRIDECETH-9 (UNII: X9HD79I514) COCOA (UNII: D9108TZ9KG) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) MALTODEXTRIN (UNII: 7CVR7L4A2D) ALLANTOIN (UNII: 344S277G0Z) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PEG-100 STEARATE (UNII: YD01N1999R) GINGER (UNII: C5529G5JPQ) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) CHLORPHENESIN (UNII: I670DAL4SZ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-280-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 06/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/12/2018 Labeler - Jafra Cosmetics International (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-280)