Label: CLE DE PEAU BEAUTE PROTECTIVE LIP TREATMENT SPF 25- avobenzone, octinoxate, and octocrylene emulsion
- NDC Code(s): 58411-856-10, 58411-856-20
- 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 January 27, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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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
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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
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Inactive Ingredients
TRIETHYLHEXANOIN ▪ DIISOSTEARYL MALATE ▪ HYDROGENATED POLYISOBUTENE ▪ PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE ▪ POLYETHYLENE ▪ TRIISOSTEARIN ▪ MICROCRYSTALLINE WAX ▪ BUTYLENE GLYCOL ▪ WATER ▪ GLYCERIN ▪ POLYGLYCERYL-2 DIISOSTEARATE ▪ TOCOPHERYL ACETATE ▪ ARGANIA SPINOSA KERNEL OIL ▪ SODIUM HYALURNATE ▪ CRATAEGUS MONOGYNA FLOWER EXTRACT ▪ THYMUS SERPYLLUM EXTRACT ▪ SODIUM ACETYLATED HYALURONATE ▪ AMINOETHANESULFINIC ACID ▪ TREHALOSE ▪ GLYCINE ▪ STEARYL GLYCYRRHETINATE ▪ PEG/PPG-14/7 DIMETHYL ETHER ▪ POTENTILLA ERECTA ROOT EXTRACT ▪ MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT ▪ ANGELICA ACUTILOBA ROOT EXTRACT ▪ HYDROLYZED CONCHIOLIN PROTEIN ▪ HYDROLYZED SILK ▪ SILICA DIMETHYL SILYLATE ▪ TOCOPHEROL ▪ SIMETHICONE ▪ BHT ▪ TRIMETHYLOLPROPANE TRIETHYLHEXANOATE ▪ METHICONE ▪ TETRADECENE ▪ SILICA ▪ THEANINE ▪ TIN OXIDE ▪ FRAGRANCE ▪ IRON OXIDES ▪ TITANIUM DIOXIDE ▪ MICA ▪
- Other information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 4 g Bottle Box
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE PROTECTIVE LIP TREATMENT SPF 25
avobenzone, octinoxate, and octocrylene emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-856 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 Inactive Ingredients Ingredient Name Strength TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIISOSTEARIN (UNII: 71503RH8KG) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ARGAN OIL (UNII: 4V59G5UW9X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) HYPOTAURINE (UNII: 5L08GE4332) TREHALOSE (UNII: B8WCK70T7I) GLYCINE (UNII: TE7660XO1C) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) POTENTILLA ERECTA ROOT (UNII: BI896CKT6B) MENTHA PIPERITA LEAF (UNII: A389O33LX6) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL) METHICONE (20 CST) (UNII: 6777U11MKT) 1-TETRADECENE (UNII: FW23481S7S) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) STANNIC OXIDE (UNII: KM7N50LOS6) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-856-20 1 in 1 BOX 08/01/2022 1 NDC:58411-856-10 4 g in 1 BOTTLE, GLASS; 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 08/01/2022 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
