![CAFE AU LAIT ALWAYS STAY-ON MAKEUP BROAD SPECTRUM SPF 15 JAFRA (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [JAFRA COSMETICS INTERNATIONAL INC]](https://medic.hrt.org//dailymed/images/55d1de30-5128-4f57-872a-98dc700aebac/carton back.jpg)
![CAFE AU LAIT ALWAYS STAY-ON MAKEUP BROAD SPECTRUM SPF 15 JAFRA (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [JAFRA COSMETICS INTERNATIONAL INC]](https://medic.hrt.org//dailymed/images/55d1de30-5128-4f57-872a-98dc700aebac/carton front.jpg)
| NDC | 68828-168-01, 68828-168-02 |
| Set ID | 55d1de30-5128-4f57-872a-98dc700aebac |
| 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
Active Ingredients Purpose
Octinoxate 5% Sunscreen
Oxybenzone 2% Sunscreen
Titanium Dioxide 2.1% Sunscreen
Uses
helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs.
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Directions
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: Ask a doctor
Sun Protection Measures. Spending time in the sun
increases your risk of skin cancer and skin aging. to decrease
this risk, regularly use a sunscreen with a Broad Spectrum SPF
value of 15 or higher and other sun measures including;
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
Water/Aqua, Cyclomethicone, Iron Oxides/CI 77491/77492/77499, Triethoxycaprylysilane, Stearic Acid, C12-15 Alkyl Benzoate, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Disteardimonium Hectorite, Propylene Carbonate, Isododecane, Trimethylsiloxysilicate, cyclopentasiloxane, Diisostearyl Polyglyceryl-3 Diisostearate, Cetyl Dimethicone Colpolyol, Glyceryl Stearate, PEG-10 Dimethicone, Talc, Dimethicone, Triethanolamine, Synthetic Wax, Propylene Glycol, Diazolidnyl Urea, Iodopropynyl Butylcarbamate, Silica Silylate, Panthenol, Trihydroxystearin, Stearoyl Inulin, Tocopheryl Acetate, Trisodium EDTA, Sodium Chloride.
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INGREDIENTS AND APPEARANCE
CAFE AU LAIT ALWAYS STAY-ON MAKEUP BROAD SPECTRUM SPF 15 JAFRA
octinoxate, oxybenzone, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-168 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) STEARIC ACID (UNII: 4ELV7Z65AP) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STEARATE (UNII: U6XF9NP8HM) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) 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 (1800 MW) (UNII: 248P1AUJ90) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PANTHENOL (UNII: WV9CM0O67Z) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE TRISODIUM (UNII: 420IP921MB) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-168-02 1 in 1 CARTON 02/22/2013 1 NDC:68828-168-01 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/22/2013 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(68828-168)
