LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50- avobenzone, homosalate, octocrylene emulsion

LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 by

Drug Labeling and Warnings

LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 by is a Otc medication manufactured, distributed, or labeled by BEL STAR SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.00%

Homosalate 10.00%

Octocrylene 8.00%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Children under 6 months of age: Ask a doctor
• 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 value 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 sleeved shirts, pants, hats, and sunglasses.

Other information

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

Inactive ingredients

WATER, BUTYLOCTYL SALICYLATE, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, POLYMETHYLSILSESQUIOXANE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, ETHYLHEXYL METHOXYCRYLENE, PHENETHYL BENZOATE, PROPYLENE GLYCOL, VP/EICOSENE COPOLYMER, SILICA, TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CETYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, FRAGRANCE, CETEARYL ALCOHOL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, CITRIC ACID, LIMONENE, LINALOOL, CITRONELLOL.

Company Information

U.S.A. & PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

Package Label

INGREDIENTS AND APPEARANCE

LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 
avobenzone, homosalate, octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-331-01	80 mL in 1 TUBE; Type 0: Not a Combination Product	06/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/12/2023

Labeler - BEL STAR SA (880160197)