Label: FACE PROTECTOR SPF 40- octinoxate oxybenzone octisalate octocrylene titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-054-13 - Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated May 14, 2012
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- ACTIVE INGREDIENT
- PURPOSE
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INACTIVE INGREDIENT
OTHER INGREDIENTS: WATER/AQUA, C12-15 ALKYL BENZOATE, ALUMINA, DIMETHICONE, ETHYLHEXYL ETHYLHEXANOATE, SODIUM DIHYDROXYCETYL PHOSPHATE, BUTYLENE GLYCOL, GLYCERYL STEARATE SE, ADIPIC ACID/DIETHYLENE GLYCOL/GLYCERIN CROSSPOLYMER, PANTHENOL, TOCOPHERYL ACETATE, AVENA SATIVA (OAT) KERNEL EXTRACT, PVP/EICOSENE COPOLYMER, CETYL ALCOHOL, XANTHAN GUM, BEESWAX/CERA ALBA, FRAGRANCE/PARFUM, IRON OXIDES/CI 77491/CI 77492/CI 77499, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, DMDM HYDANTOIN, TRISODIUM EDTA.
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
- WARNINGS
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INGREDIENTS AND APPEARANCE
FACE PROTECTOR SPF 40
octinoxate oxybenzone octisalate octocrylene titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-054 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALUMINUM OXIDE (UNII: LMI26O6933) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL ETHYLHEXANOATE (UNII: 430RJA6715) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) DIETHYLENE GLYCOL ADIPATE (UNII: 6KE5V549E0) OAT (UNII: Z6J799EAJK) POVIDONE K30 (UNII: U725QWY32X) CETYL ALCOHOL (UNII: 936JST6JCN) YELLOW WAX (UNII: 2ZA36H0S2V) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PEG-4 LAURATE (UNII: AYF4VM3N1Z) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-054-13 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/24/2012 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture