SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER- octinoxate lipstick

SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER by

Drug Labeling and Warnings

SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER 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

OCTINOXATE 4.9%

Purpose

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

POLYGLYCERYL-2 TRIISOSTEARATE, TRIISOSTEARIN, MACADAMIA TERNIFOLIA SEED OIL, POLYETHYLENE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, MICROCRYSTALLINE WAX, EUPHORBIA CERIFERA (CANDELILLA) WAX, WATER, SODIUM MAGNESIUM SILICATE, GLYCERIN, ARGININE HCl, XYLITOL, TOCOPHERYL ACETATE, ALLANTOIN, SODIUM HYALURONATE, PEG-10 DIMETHICONE, TOCOPHEROL, DIMETHICONE, DIISOSTEARYL MALATE, BHT, METHICONE, TETRADECENE, SILICA, POLYSILICONE-2, FRAGRANCE, MICA, TITANIUM DIOXIDE, IRON OXIDES,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO DIST.
NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

SHISEIDO

The Skincare

Protective
Lip Conditioner
SPF 12
SUNSCREEN

4g NET WT. .14 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	196 mg  in 4 g

Inactive Ingredients
Ingredient Name	Strength
TRIISOSTEARIN (UNII: 71503RH8KG)
MACADAMIA OIL (UNII: 515610SU8C)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CANDELILLA WAX (UNII: WL0328HX19)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
XYLITOL (UNII: VCQ006KQ1E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALLANTOIN (UNII: 344S277G0Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-134-20	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(52686-134) , analysis(52686-134)