SHISEIDO SUN PROTECTION LIP TREATMENT- octinoxate and titanium dioxide lipstick

SHISEIDO SUN PROTECTION LIP TREATMENT by

Drug Labeling and Warnings

SHISEIDO SUN PROTECTION LIP TREATMENT 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 7.4%	Sunscreen
TITANIUM DIOXIDE 4.5%	Sunscreen

Use

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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
• children under 6 months: Ask a doctor

Inactive Ingredients

TRIETHYLHEXANOIN, POLYGLYCERYL-2 TRIISOSTEARATE, TRIISOSTEARIN, HYDROGENATED POLYISOBUTENE, POLYETHYLENE, PEG/PPG-36/41 DIMETHYL ETHER, MICROCRYSTALLINE WAX, STEARYL GLYCYRRHETINATE, GLUTATHIONE, ZINC MYRISTATE, THIOTAURINE, SODIUM ACETYLATED HYALURONATE, ALUMINUM HYDROXIDE, TOCOPHEROL, DIISOSTEARYL MALATE, SODIUM MAGNESIUM SILICATE, GLYCERIN, BHT, FRAGRANCE,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

SHI SEIDO

SPF 35

Sun Protection
Lip Treatment

SUNSCREEN

4g NET WT. .14 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SUN PROTECTION LIP TREATMENT 
octinoxate and titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-642
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	296 mg  in 4 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	180 mg  in 4 g

Inactive Ingredients
Ingredient Name	Strength
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
TRIISOSTEARIN (UNII: 71503RH8KG)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
GLUTATHIONE (UNII: GAN16C9B8O)
ZINC MYRISTATE (UNII: K09A9E2GGO)
THIOTAURINE (UNII: NQZ2D7AO62)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-642-20	1 in 1 CARTON	10/01/2012
1		4 g in 1 CARTRIDGE; 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	10/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(52686-642) , analysis(52686-642)