SHISEIDO PROTECTIVE LIP CONDITIONER- octinoxate stick

SHISEIDO PROTECTIVE LIP CONDITIONER by

Drug Labeling and Warnings

SHISEIDO PROTECTIVE LIP CONDITIONER by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OCTINOXATE 4.9%

Purpose

Sunscreen

Uses

• 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 TRIISOSTEARATETRIISOSTEARINMACADAMIA TERNIFOLIA SEED OILPOLYETHYLENEDIPHENYLSILOXY PHENYL TRIMETHICONETRIETHYLHEXANOINMICROCRYSTALLINE WAXEUPHORBIA CERIFERA (CANDELILLA) WAXSODIUM MAGNESIUM SILICATEGLYCERINWATERARGININE HClXYLITOLTOCOPHERYL ACETATEALLANTOINSODIUM HYALURONATEPEG-10 DIMETHICONETOCOPHEROLSIMETHICONEBHTTRIMETHYLOLPROPANE TRIETHYLHEXANOATEMETHICONETETRADECENESILICAALUMINUM HYDROXIDEPOLYSILICONE-2FRAGRANCEMICATITANIUM DIOXIDEIRON 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

PRINCIPAL DISPLAY PANEL - 4 g Cartridge Carton

SHI SEIDO

Protective
Lip Conditioner

SPF 12
SUNSCREEN

4g NET WT. .14 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO PROTECTIVE LIP CONDITIONER 
octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-257
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
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
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)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
XYLITOL (UNII: VCQ006KQ1E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-257-20	1 in 1 CARTON	09/01/2015
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	09/01/2015

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-257) , analysis(58411-257)