BIORESIST REINFORCING EFFECT FACE MOISTURIZER SPF 30- avobenzone, octisalate, octocrylene cream 
Ventura International 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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Bioresist reinforcing effect face moisturizer Lotion SPF 30

Active Ingredients Purpose

Avobenzone 1.80% Sunscreen

Octisalate 4.50% Sunscreen

Octocrylene 4.50% Sunscreen

Uses

Helps prevent Sunburn

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center righ away

Stop use and ask a doctor if rash occurs

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 reach of children

Directions

Inactive ingredients

Water, glycerin, butyloctyl salicylate, c12-15 alkyl benzoate, ethylhexyl methoxycrylene, behenyl alcohol, glyceryl stearate, coco-caprylate, Sodium pca, sodium acrylates copolymer, potassium cetyl phosphate, palmitic acid, stearic acid, silica, squalane, lecithin, hydroxyacetophenone, xanthan gum, 1,2- hexandiol, caprylyl glycol, cetyl alcohol, lauryl alcohol, myristyl alcohol, butylene glycol, acacia senegal gum, yeast extract, arginine, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sclerotium gum, tetrasodium edta, pullulan, fragrance, hydrolyzed soybean fiber, phenoxyethanol, nicotiana benthmiana hexapeptide-40 sh-oligopepride-1, butylphenyl methylpropional , d-limonene, linalool, citronellol

L'Bel

Bioresist

reinforcing effect face moisturizer lotion SPF 30

1 fl. oz. e (30 ml)

Label update C

BIORESIST REINFORCING EFFECT FACE MOISTURIZER SPF 30 
avobenzone, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
ACACIA (UNII: 5C5403N26O)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
ARGININE (UNII: 94ZLA3W45F)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PALMITIC ACID (UNII: 2V16EO95H1)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
LAURYL ALCOHOL (UNII: 178A96NLP2)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SQUALANE (UNII: GW89575KF9)  
2',3'-DIHYDROXYACETOPHENONE (UNII: 65328I5OQP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-142-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
2NDC:14783-142-025 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2020
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
BEL STAR S A880160197manufacture(14783-142)

Revised: 2/2021
Document Id: bc091e94-be7c-56ae-e053-2a95a90a0f6b
Set id: 05794bbb-7206-4cd0-a944-58b80ccfd8e6
Version: 2
Effective Time: 20210223
 
Ventura International LTD