Label: CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT- avobenzone, octinoxate, octocrylene, and oxybenzone stick
- NDC Code(s): 58411-288-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 13, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
-
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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 4 g Bottle Carton
-
INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT
avobenzone, octinoxate, octocrylene, and oxybenzone stickProduct 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)
