SHISEIDO REFINING MAKEUP PRIMER- octinoxate and titanium dioxide cream

SHISEIDO REFINING MAKEUP PRIMER by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 7.4%	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

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.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

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, TITANIUM DIOXIDE

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

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SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

SHISEIDO

Refining
Makeup Primer

BROAD SPECTRUM
SPF 21
sunscreen

30mL
NET WT. 1.1 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO REFINING MAKEUP PRIMER 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1661 mg  in 33.9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2509 mg  in 33.9 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)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOSTEARIC ACID (UNII: X33R8U0062)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
EDETATE TRISODIUM (UNII: 420IP921MB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TOCOPHEROL (UNII: R0ZB2556P8)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-276-60	1 in 1 CARTON	09/01/2010
1		33.9 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(52686-276) , ANALYSIS(52686-276)