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

cle de peau BEAUTE PROTECTIVE LIP TREATMENT by

Drug Labeling and Warnings

cle de peau BEAUTE PROTECTIVE LIP TREATMENT by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 3.0%	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

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

• 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 Box

clé de peau
BEAUTÉ

PROTECTIVE
LIP TREATMENT

25
BROAD SPECTRUM
SPF 25
SUNSCREEN

4g NET WT. .14 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE PROTECTIVE LIP TREATMENT   SPF 25
avobenzone, octinoxate, and octocrylene emulsion

Product 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)