CLE DE PEAU BEAUTE PROTECTIVE LIP TREATMENT  SPF 25- avobenzone, octinoxate, and octocrylene emulsion 
SHISEIDO AMERICAS CORPORATION

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.

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clé de peau BEAUTÉ PROTECTIVE LIP TREATMENT
SPF 25

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen

Uses

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:

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?

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PRINCIPAL DISPLAY PANEL - 4 g Bottle Box

clé de peau
BEAUTÉ

PROTECTIVE
LIP TREATMENT

25
BROAD SPECTRUM
SPF 25
SUNSCREEN

4g NET WT. .14 OZ.

PRINCIPAL DISPLAY PANEL - 4 g Bottle Box
CLE DE PEAU BEAUTE PROTECTIVE LIP TREATMENT   SPF 25
avobenzone, octinoxate, and octocrylene emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-856
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-856-201 in 1 BOX08/01/2022
1NDC:58411-856-104 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2022
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 1/2023
Document Id: 296d61b8-94b2-4fb9-89d0-dcf157e943b4
Set id: addd9885-362c-4ce0-9a6e-759e71d8756c
Version: 1
Effective Time: 20230127
 
SHISEIDO AMERICAS CORPORATION