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

Sienna Always Color Stay-on Makeup Broad Spectrum SPF 15 by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients      Purpose

Octinoxate 5%           Sunscreen

Oxybenzone 2%         Sunscreen

Titanium Dioxide 2.1%   Sunscreen

Uses

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 product is 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.

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun

increases your risk of skin cancer and skin aging. to decrease

this risk, regularly use a sunscreen with a Broad Spectrum SPF

value of 15 or higher and other sun measures including;

limit time in the sun, especially from 10 a.m. - 2 p.m.

wear long-sleeve shirts, pants, hats, and sunglasses

Water/Aqua, Cyclomethicone, Iron Oxides/CI 77491/77492/77499, Triethoxycaprylysilane, Stearic Acid, C12-15 Alkyl Benzoate, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Disteardimonium Hectorite, Propylene Carbonate, Isododecane, Trimethylsiloxysilicate, cyclopentasiloxane, Diisostearyl Polyglyceryl-3 Diisostearate, Cetyl Dimethicone Colpolyol, Glyceryl Stearate, PEG-10 Dimethicone, Talc, Dimethicone, Triethanolamine, Synthetic Wax, Propylene Glycol, Diazolidnyl Urea, Iodopropynyl Butylcarbamate, Silica Silylate, Panthenol, Trihydroxystearin, odium Chloride, Stearoyl Inulin, Trisodium EDTA, Tcopheryl Acetate.

PRINCIPAL DISPLAY PANEL

Jafra

Always Color stay-on makeup Broad Spectrum SPF 15 Sienna

30 ml 1fl oz

INGREDIENTS AND APPEARANCE

SIENNA 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: 68828-184
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	2.29 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)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TROLAMINE (UNII: 9O3K93S3TK)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PANTHENOL (UNII: WV9CM0O67Z)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE TRISODIUM (UNII: 420IP921MB)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-184-02	1 in 1 CARTON	12/12/2013
1	NDC: 68828-184-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/12/2013

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(68828-184)