OTC Medication Information: Cafe Au Lait Always Color Stay-On Makeup SPF 10

CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10- titanium dioxide and octinoxate lotion
Jafra Cosmetics International Inc

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.

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.

image of box back label
(click image for full-size original)

Jafra

Always Color Stay-On

Maquillaje Facial de Larga

Duracion FPS 10

30 ml 1 Fl Oz (US)

image of box front
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 8 mL in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.5 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE
ALKYL (C12-15) BENZOATE
ALUMINUM OXIDE
ALUMINUM STEARATE
POLYHYDROXYSTEARIC ACID (2300 MW)
STEARIC ACID
PROPYLENE CARBONATE
ISODODECANE
TRIMETHYLSILOXYSILICATE (M/Q 0.66)
CYCLOMETHICONE 5
GLYCERYL MONOSTEARATE
PEG-10 DIMETHICONE (600 CST)
TALC
DIMETHICONE
TROLAMINE
SYNTHETIC WAX (1900 MW)
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
PROPYLPARABEN
BUTYLPARABEN
PROPYLENE GLYCOL
DIAZOLIDINYL UREA
IODOPROPYNYL BUTYLCARBAMATE
PANTHENOL
SODIUM CHLORIDE
.ALPHA.-TOCOPHEROL ACETATE
EDETATE TRISODIUM
TRIETHOXYCAPRYLYLSILANE
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-083-01 1 BOTTLE, GLASS (BOTTLE) in 1 BOX contains a BOTTLE, GLASS
1 30 mL in 1 BOTTLE, GLASS This package is contained within the BOX (68828-083-01)
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 Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture

Revised: 05/2012 Jafra Cosmetics International Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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