NDC Code(s) : 58411-288-10
Packager : SHISEIDO AMERICAS CORPORATION

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENTAVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-288
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE100 mg in 4 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE196 mg in 4 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE120 mg in 4 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE80 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
1NDC:58411-288-101 in 1 CARTON 02/01/2017
14 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)

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

30

UV protective
lip treatment

BROAD SPECTRUM
SPF 30
SUNSCREEN

4g NET WT. .14 OZ.

Principal Display Panel - 4 g Bottle Carton