BIORESIST REINFORCING EFFECT FACE MOISTURIZER SPF 30- avobenzone, octisalate, octocrylene cream

Bioresist reinforcing effect face moisturizer SPF 30 by

Drug Labeling and Warnings

Bioresist reinforcing effect face moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, BEL STAR S A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 1.80% Sunscreen

Octisalate 4.50% Sunscreen

Octocrylene 4.50% Sunscreen

PURPOSE

Uses

Helps prevent Sunburn

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

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 reach of children

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

L'Bel

Bioresist

reinforcing effect face moisturizer lotion SPF 30

1 fl. oz. e (30 ml)

INGREDIENTS AND APPEARANCE

BIORESIST REINFORCING EFFECT FACE MOISTURIZER SPF 30 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-142
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-142-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
2	NDC: 14783-142-02	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2020

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
BEL STAR S A		880160197	manufacture(14783-142)