CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT- avobenzone, octinoxate, octocrylene, and oxybenzone stick

CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT 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 INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
OXYBENZONE 2.0%	Sunscreen

Uses

• helps prevent sunburn

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

DIISOSTEARYL MALATETRIETHYLHEXANOINHYDROGENATED POLYISOBUTENETRIISOSTEARINPHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATEPOLYETHYLENEMICROCRYSTALLINE WAXWATERBUTYLENE GLYCOLGLYCERINPOLYGLYCERYL-2 DIISOSTEARATETOCOPHERYL ACETATEPEG/PPG-36/41 DIMETHYL ETHERARGANIA SPINOSA KERNEL OILSTEARYL GLYCYRRHETINATEMORTIERELLA OILGINKGO BILOBA LEAF EXTRACTTHYMUS SERPYLLUM EXTRACTPANAX GINSENG ROOT EXTRACTSODIUM ACETYLATED HYALURONATESODIUM HYALURONATESILICA DIMETHYL SILYLATELITHIUM MAGNESIUM SODIUM SILICATETOCOPHEROLSIMETHICONEBHTALCOHOLTRIMETHYLOLPROPANE TRIETHYLHEXANOATEMETHICONETETRADECENEFRAGRANCEIRON 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 Bottle Carton

clé de peau
BEAUTÉ

30

UV protective
lip treatment

BROAD SPECTRUM
SPF 30
SUNSCREEN

4g NET WT. .14 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT 
avobenzone, octinoxate, octocrylene, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-288
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	100 mg  in 4 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	196 mg  in 4 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	120 mg  in 4 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	80 mg  in 4 g

Inactive Ingredients
Ingredient Name	Strength
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TRIISOSTEARIN (UNII: 71503RH8KG)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ARGAN OIL (UNII: 4V59G5UW9X)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
GINKGO (UNII: 19FUJ2C58T)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
ASIAN GINSENG (UNII: CUQ3A77YXI)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
LAPONITE (UNII: D703131383)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-288-10	1 in 1 CARTON	02/01/2017
1		4 g in 1 BOTTLE; 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	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-288) , analysis(58411-288)