SHISEIDO MAKEUP REFINING MAKEUP PRIMER- octinoxate and titanium dioxide cream

SHISEIDO MAKEUP REFINING MAKEUP PRIMER by

Drug Labeling and Warnings

SHISEIDO MAKEUP REFINING MAKEUP PRIMER by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 7.5%	Sunscreen

Uses

• helps prevent sunburn
• -higher SPF gives more sunburn protection

Warnings

For external use only.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply evenly before sun exposure and as needed.
• children under 6 months of age: ask a doctor.

Inactive Ingredient List

CYCLOMETHICONE, WATER, DIPROPYLENE GLYCOL, SILICA, GLYCERIN, POLYMETHYLSILSESQUIOXANE, POLYMETHYL METHACRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, DISTEARDIMONIUM HECTORITE, TRIMETHYLSILOXYSILICATE, PEG/PPG-36/41 DIMETHYL ETHER, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ALUMINUM DISTEARATE, ALUMINUM HYDROXIDE, ISOSTEARIC ACID, TRISODIUM EDTA, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, POLYSILICONE-2, BHT, TOCOPHEROL, METHICONE, TETRADECENE, PHENOXYETHANOL, IRON OXIDES, MICA

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Carton

SHI SEIDO

Refining
Makeup Primer

SPF 21
sunscreen

30mL
NET WT. 1.1OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO MAKEUP REFINING MAKEUP PRIMER 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-229
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.528016 g  in 31.184 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.3388 g  in 31.184 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ISOSTEARIC ACID (UNII: X33R8U0062)
EDETATE TRISODIUM (UNII: 420IP921MB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-229-60	1 in 1 CARTON	09/01/2010
1		31.184 g 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	09/01/2010

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(52686-229) , analysis(52686-229)