Label: MOISTURIZING MAKEUP SPF 15- octinoxate octisalate oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-048-11, 68828-048-67 - 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 May 1, 2012
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- ACTIVE INGREDIENT
- PURPOSE
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INACTIVE INGREDIENT
OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL PALMITATE, ISOPROPYL ISOSTEARATE, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, SILICA, DI-PPG-3 MYRISTYL ETHER ADIPATE, GLYCERYL STEARATE, STEARIC ACID, SACCHARIDE ISOMERATE, POLYSORBATE 20, LECITHIN, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, POLYSILICONE-11, LAURETH-12, CYCLOPENTASILOXANE, ACRYLATES/DIMETHICONE COPOLYMER, METHYLSILANOL MANNURONATE, DMDM HYDANTOIN, TRIHYDROXYSTEARIN, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, VIGNA RADIATA (MUNG BEAN) EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, FRAGRANCE/PARFUM, TETRASODIUM EDTA, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, BORAGO OFFICINALIS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ALGAE EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499, TITANIUM DIOXIDE/CI 77891] [FRAGRANCE/PARFUM CONTAINS: LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL (LILIAL), CITRONELLOL]
- INDICATIONS & USAGE
- INSTRUCTIONS FOR USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOISTURIZING MAKEUP SPF 15
octinoxate octisalate oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-048 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 PALMITATE (UNII: 8CRQ2TH63M) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) POLYSORBATE 20 (UNII: 7T1F30V5YH) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYSILICONE-15 (UNII: F8DRP5BB29) LAURETH-12 (UNII: OAH19558U1) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) DMDM HYDANTOIN (UNII: BYR0546TOW) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) XANTHAN GUM (UNII: TTV12P4NEE) PANTHENOL (UNII: WV9CM0O67Z) IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79) WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082) MUNG BEAN (UNII: 1LIB31N73G) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BORAGE (UNII: PB618V0K2W) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) JOJOBA OIL (UNII: 724GKU717M) EDETATE SODIUM (UNII: MP1J8420LU) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SHEA BUTTER (UNII: K49155WL9Y) METHYLSILANOL ACETYLMETHIONATE (UNII: FKT0KP5RFC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-048-11 1 in 1 BOX 1 NDC:68828-048-67 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 05/01/2012 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
