Label: SKIN DEFENSE MAKEUP SPF 15- octinoxate octisalate oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-047-11, 68828-047-67 - Packager: JAFRA COSMETICS INTERNATIONAL
- 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 April 27, 2012
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- ACTIVE INGREDIENT
- PURPOSE
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INACTIVE INGREDIENT
OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL ISOSTEARATE, DI-PPG-3 MYRISTYL ETHER ADIPATE, STEARIC ACID, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE, LECITHIN, POLYETHYLENE, METHYL METHACRYLATE COPOLYMER, SILICA, DIMETHICONE, SODIUM HYALURONATE, TREHALOSE, SODIUM PCA, POLYQUATERNIUM-51, UREA, GLYCERIN, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYSORBATE 20, TRIETHANOLAMINE, TAGETUS ERECTA (AFRICAN MARIGOLD) EXTRACT, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, PROPYLENE GLYCOL, MACROCYSTIS PYRIFERA EXTRACT, HYDROLYZED WHEAT PROTEIN, PVP, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, FRAGRANCE/PARFUM, PANTHENOL, TOCOPHERYL ACETATE, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA [MAY CONTAIN, +/-: TITANIUM DIOXIDE/CI 77891, IRON OXIDES/CI 77491/CI 77492/CI 77499] [FRAGRANCE/PARFUM CONTAINS: CITRONELLOL, ALPHA-ISOMETHYL IONONE, GERANIOL, LIMONENE, LINALOOL].
- INDICATIONS & USAGE
- INSTRUCTIONS FOR USE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SKIN DEFENSE MAKEUP SPF 15
octinoxate octisalate oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-047 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) STEARIC ACID (UNII: 4ELV7Z65AP) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ZINC OXIDE (UNII: SOI2LOH54Z) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) METHYL METHACRYLATE (UNII: 196OC77688) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TREHALOSE (UNII: B8WCK70T7I) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G) UREA (UNII: 8W8T17847W) GLYCERIN (UNII: PDC6A3C0OX) OAT (UNII: Z6J799EAJK) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) TAGETES ERECTA FLOWER (UNII: UH5X33P33E) IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) POVIDONE K30 (UNII: U725QWY32X) DMDM HYDANTOIN (UNII: BYR0546TOW) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) XANTHAN GUM (UNII: TTV12P4NEE) CHONDRUS CRISPUS (UNII: OQS23HUA1X) PANTHENOL (UNII: WV9CM0O67Z) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EDETATE TRISODIUM (UNII: 420IP921MB) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-047-67 1 in 1 BOX 1 NDC:68828-047-11 30 mL in 1 BOTTLE 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)