Drug Facts

Active Ingredients

Avobenzone 1.80%

Octisalate 4.50%

Octocrylene 4.50%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Water, glycerin, c12-15 alkyl benzoate, butyloctyl salicylate, cyclohexasiloxane, ethylhexyl methoxycrylene, potassium cetyl phosphate, triethylhexanoin, hydrogenated palm glycerides, glyceryl stearate, peg-100 stearate, synthetic fluorphlogopite, hydroxyacetophenone, titanium dioxide, acrylates/c10-30 alkyl acrylate crosspolymer, vigna aconitifolia seed extract, xanthan gum, 1,2-hexanediol, caprylyl glycol, cetearyl isononanoate, sodium cocoyl glutamate, acacia senegal gum, dimethylmethoxy chromanyl palmitate, tetrasodium edta, ceteareth-20, cetearyl alcohol, sodium hydroxide, hydrolyzed algin, ceteareth-12, cetyl palmitate, phenoxyethanol, tin oxide.

Package Label

LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30
avobenzone, octisalate, octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-332
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	18 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
MOTH BEAN (UNII: H7938ON8E5)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE SODIUM (UNII: MP1J8420LU)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ACACIA (UNII: 5C5403N26O)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETEARETH-12 (UNII: 7V4MR24V5P)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-332-01	1 in 1 BOX	06/20/2023
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	06/20/2023

Labeler - BEL STAR SA (880160197)

LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30