CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10- titanium dioxide, octinoxate/ethylhexylmehtoxycinnamate lotion

Cafe Au Lait by

Drug Labeling and Warnings

Cafe Au Lait by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sunscreen Active Ingredient (SPF 10): Titanium Dioxide, Octinoxate/Ethylhexyl Methoxycinnamate

Uses:  sunscreen

Keep out of reach of children

Discontinue use if signs of irritation occur.

Caution: For external use only. Avoid contact with eyes. Clinically, Allergy, and irritancy tested. Dermatologist tested.

To use: Shake well. Smooth on with fingers or sponge.

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

Jafra

Always Color Stay-On

Maquillaje Facial de Larga

Duracion FPS 10

30 ml 1 Fl Oz (US)

INGREDIENTS AND APPEARANCE

CAFE AU LAIT  ALWAYS COLOR STAY-ON MAKEUP SPF 10
titanium dioxide, octinoxate/ethylhexylmehtoxycinnamate lotion

Product 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