ALWAYS COLOR STAY ON MAKEUP BROAD SPECTRUM SPF 15 JAFRA- octinoxate, oxybenzone, titanium dioxide cream

Always Color Stay on Makeup Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Always Color Stay on Makeup Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Octinoxate 5.0%

Oxybenzone 2.0%

Titanium Dioxide 7.3 %

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 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

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Inactive Ingredients

Water/Aqua, Cyclomethicone, Iron Oxides/CI 77491/CI 77492/CI 77499, Triethoxycaprylysilane, Stearic Acid, C12-15 Alkyl Benzoate, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Disteardimonium Hectorite, Propylene Carbonate, Isododecane, Trimethylsiloxysilicate, Cyclopentasiloxane, Diisostearoyl Polyglyceryl-3 Diisostearate, Cetyl Dimethicone Copolyol, Glyceryl Stearate, PEG-10 Dimethicone, Talc, Dimethicone, Triethanolamine, Synthetic Wax, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Silica Silylate, Panthenol, Stearoyl Inulin, Tocopheryl Acetate, Trisodium EDTA, Sodium Chloride

PRINCIPAL DISPLAY PANEL

Jafra Tester Always Color Stay on Makeup Broad Spectrum SPF 15

Contains: 10 testers at.27 FL OZ each

CONT. NET. 80 ml 2.7 FL OZ (US)

INGREDIENTS AND APPEARANCE

ALWAYS COLOR STAY ON MAKEUP BROAD SPECTRUM SPF 15  JAFRA
octinoxate, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-164
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	7.3 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)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PANTHENOL (UNII: WV9CM0O67Z)
.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: 68828-164-02	10 in 1 CARTON	11/26/2012
1	NDC: 68828-164-01	79.85 mL in 1 TUBE; 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	11/26/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-164)