![OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]](https://medic.hrt.org//dailymed/images/63592ad9-283f-46bb-9837-b72a53159cbb/Oil Control Make-Up Labeling (04-2012).jpg)
| NDC | 68828-046-11, 68828-046-67 |
| Set ID | 63592ad9-283f-46bb-9837-b72a53159cbb |
| Category | HUMAN OTC DRUG LABEL |
| Packager | JAFRA COSMETICS INTERNATIONAL |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
-
INACTIVE INGREDIENT
OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL PALMITATE, ISOPROPYL ISOSTEARATE, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE, DI-PPG-3 MYRISTYL ETHER ADIPATE, SILICA, STEARIC ACID, ZINC OXIDE/CI 77947, POLYSORBATE 20, LECITHIN, POLYSILICONE-11, LAURETH-12, CYCLOPENTASILOXANE, ACRYLATES/DIMETHICONE COPOLYMER, DMDM HYDANTOIN, TRIHYDROXYSTEARIN, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, PANTHENOL, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, VIGNA RADIATA (MUNG BEAN) EXTRACT, TOCOPHERYL ACETATE, HAMAMELIS VIRGINIA (WITCH HAZEL) EXTRACT, SYMPHYTUM OFFICINALIS LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, CUCUMIS SATIVAS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, ALTHAEA OFFICINALIS ROOT EXTRACT, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, FRAGRANCE/PARFUM, TRISODIUM EDTA, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499, TITANIUM DIOXIDE/CI 77891] [FRAGRANCE/PARFUM CONTAINS: LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL (LILIAL), CITRONELLOL]
- DESCRIPTION
- INDICATIONS & USAGE
- INSTRUCTIONS FOR USE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OIL CONTROLLING MAKEUP SPF 15
octinoxate octisalate oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-046 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) ZINC OXIDE (UNII: SOI2LOH54Z) 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) HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) COMFREY LEAF (UNII: DG4F8T839X) CHAMOMILE (UNII: FGL3685T2X) CUCUMBER (UNII: YY7C30VXJT) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) TEA TREE OIL (UNII: VIF565UC2G) EDETATE TRISODIUM (UNII: 420IP921MB) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-046-67 1 in 1 BOX 1 NDC:68828-046-11 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 04/19/2012 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
