Label: JAFRA ALWAYS COLOR STAY-ON MAKEUP SPF 10- titanium dioxide, octinoxate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-106-01, 68828-106-02 - Packager: Jafra Cosmetics International Inc
- Category: HUMAN PRESCRIPTION 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 August 28, 2012
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Sunscreen Active Ingredient (SPF 10): Titanium Dioxide, Octinoxate/Ethylhexyl Methoxycinnamate.
Sunscreen
Keep out of reach of children
Discontinue use of signs of irritation occur
Caution: For External Use only. Avoid contact with eyes.
no such information
Water/Aqua, Cyclomethicone, C12-15 Alkyl Benzoate, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Stearic Acid, Disteardimonium Hectorite, Propylene Carbonate, Isododecane, Diisostearyl Polyglyceryl-3 Diisostearate, Trimethylsiloxysilicate, Cyclopentasiloxane, Glyceryl stearate, PEG-10 Dimethicone, Talc, Dimethicone, Triethanolamine, Synthetic Wax, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Silica Silylate, Stearoyl inulin, panthenol, Sodium Chloride, Tocopheryl Acetate, Trisodium EDTA, Triethoxycaprylysilane, [May contain /+/- =: Titanium DIoxide/CI77891, Iron Oxides/CI77491/77492/77499].
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JAFRA ALWAYS COLOR STAY-ON MAKEUP SPF 10
titanium dioxide, octinoxate liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68828-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.4 mL in 80 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 mL in 80 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) C12-15 ALKYL 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) 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) 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:68828-106-02 10 in 1 PACKAGE 1 NDC:68828-106-01 8 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/30/2012 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(68828-106)
