LBEL DEFENSE TOTAL BROAD SPECTRUM SPF 50PLUS SUNSCREEN FOR FACE AND BODY- avobenzone, homosalate, and octocrylene lotion 
Ventura Corporation LTD

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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L'BEL DEFENSE TOTAL broad spectrum SPF 50+ sunscreen lotion for face and body

Drug Facts

Active IngredientsPurpose
AVOBENZONE 3.00%Sunscreen
HOMOSALATE 10.00%Sunscreen
OCTOCRYLENE 8.00%Sunscreen

Uses

Warnings

  • 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

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, FRAGRANCE, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CITRIC ACID, OXOTHIAZOLIDINE, d-LIMONENE, LINALOOL, CITRONELLOL.

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926

PRINCIPAL DISPLAY PANEL - 80 ml Bottle Label

L'BEL
DÉFENSE
TOTAL

HIGH PROTECTION
SPF
50+

broad spectrum
sunscreen lotion
for face and body

WITH COLLAGEN
BIO-PROTECTORS

WATER RESISTANT
(40 minutes)

80 ml e (2.7 fl.oz.)

PRINCIPAL DISPLAY PANEL - 80 ml Bottle Label
LBEL DEFENSE TOTAL BROAD SPECTRUM SPF 50PLUS SUNSCREEN FOR FACE AND BODY 
avobenzone, homosalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-990
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.1 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.08 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-990-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/23/2016
2NDC:13537-990-0280 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/23/2016
3NDC:13537-990-041 in 1 BOX08/23/2016
3NDC:13537-990-0310 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:13537-990-055 mL in 1 PACKET; Type 0: Not a Combination Product08/23/2016
5NDC:13537-990-061 mL in 1 PACKET; Type 0: Not a Combination Product08/23/2016
6NDC:13537-990-081 in 1 CARTON08/23/2016
6NDC:13537-990-070.07 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/23/2016
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-990)

Revised: 11/2020
Document Id: b4f5c39f-773d-2aac-e053-2a95a90aefb6
Set id: e5379629-31d3-41b4-bfe6-c7cd7bfbe0e2
Version: 2
Effective Time: 20201125
 
Ventura Corporation LTD