Drug Facts

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 MALATE•TRIETHYLHEXANOIN•HYDROGENATED POLYISOBUTENE•TRIISOSTEARIN•PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE•POLYETHYLENE•MICROCRYSTALLINE WAX•WATER•BUTYLENE GLYCOL•GLYCERIN•POLYGLYCERYL-2 DIISOSTEARATE•TOCOPHERYL ACETATE•PEG/PPG-36/41 DIMETHYL ETHER•ARGANIA SPINOSA KERNEL OIL•STEARYL GLYCYRRHETINATE•MORTIERELLA OIL•GINKGO BILOBA LEAF EXTRACT•THYMUS SERPYLLUM EXTRACT•PANAX GINSENG ROOT EXTRACT•SODIUM ACETYLATED HYALURONATE•SODIUM HYALURONATE•SILICA DIMETHYL SILYLATE•LITHIUM MAGNESIUM SODIUM SILICATE•TOCOPHEROL•SIMETHICONE•BHT•ALCOHOL•TRIMETHYLOLPROPANE TRIETHYLHEXANOATE•METHICONE•TETRADECENE•FRAGRANCE•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

PRINCIPAL DISPLAY PANEL - 4 g Bottle Carton

clé de peau
BEAUTÉ

UV protective
lip treatment

BROAD SPECTRUM
SPF 30
SUNSCREEN

4g NET WT. .14 OZ.

Principal Display Panel - 4 g Bottle Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

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