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![CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]](https://medic.hrt.org//dailymed/images/d91138de-e6b8-469f-96bf-ea73a872cd27/front.jpg)
| NDC | 68828-083-01 |
| Set ID | d91138de-e6b8-469f-96bf-ea73a872cd27 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Jafra Cosmetics International Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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ACTIVE INGREDIENT
Sunscreen Active Ingredient (SPF 10): Titanium Dioxide, Octinoxate/Ethylhexyl Methoxycinnamate
Caution: For external use only. Avoid contact with eyes. Clinically, Allergy, and irritancy tested. Dermatologist tested.
Other ingredients:
Water/Aqua, Cyclomethicone, C12-15 Alkyl Benzoate, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Stearic Acid, Disteardimonium Hectorite, Propylene Glycol, Diazolidnyl Urea, Iodopropynyl Butylcarbamate, Silica Silylate, Stearoyl Inulin, Panthenol, Sodium Chloride, Tocopheryl Acetate, Trisodium EDTA, Triethoxycaprylysilane.
May Contain /+/-: Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/77492/77499.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10
titanium dioxide, octinoxate/ethylhexylmehtoxycinnamate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 8 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STEARATE (UNII: U6XF9NP8HM) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TALC (UNII: 7SEV7J4R1U) DIMETHICONE (UNII: 92RU3N3Y1O) TROLAMINE (UNII: 9O3K93S3TK) SYNTHETIC WAX (1900 MW) (UNII: 5M631N9V0S) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PANTHENOL (UNII: WV9CM0O67Z) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE TRISODIUM (UNII: 420IP921MB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 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:68828-083-01 1 in 1 BOX 1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/16/2012 Labeler - Jafra Cosmetics International Inc (041676479) Registrant - Jafra Cosmetics International Inc (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture
