Always Color Stay-On Makeup SPF 10

GOLDEN TAN 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.

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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

Jafra

Always Color Stay-On

Maquillaje Facial de Larga

Duracion FPS 10

30 ml 1 Fl Oz (US)

image of box front

GOLDEN TAN ALWAYS COLOR STAY-ON MAKEUP SPF 10
titanium dioxide, octinoxate/ethylhexylmehtoxycinnamate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-086
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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:68828-086-01	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 (68828-086-01)

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