Label: BRIGHTENING AND MOISTURIZING FACIAL SPF 30- avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 26, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    AVOBENZONE 3.00%Sunscreen
    ENSULIZOLE 3.00 %Sunscreen
    OCTISALATE 5.00 %Sunscreen
    OCTOCRYLENE 5.00 %Sunscreen
    OXYBENZONE 6.00 %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, DICAPRYLYL CARBONATE, CETEARYL ALCOHOL, PHENETHYL BENZOATE, TRIETHANOLAMINE, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SORBITAN STEARATE, TRIETHYLHEXANOIN, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, DIMETHICONE, STEARYL DIMETHICONE, CETEARETH-20, XANTHAN GUM, CETYL ALCOHOL, GLYCERYL STEARATE, CHLORPHENESIN, FRAGRANCE, VIGNA ACONITIFOLIA SEED EXTRACT, DIMETHYLMETHOXY CHROMANYL PALMITATE, PEG-75 STEARATE, SODIUM COCOYL GLUTAMATE, TETRASODIUM EDTA, CETETH-20, STEARETH-20, BUTYLPARABEN, SORBIC ACID, METHYLPARABEN, ALPHA-ISOMETHYL IONONE, HYDROXYCITRONELLAL, d-LIMONENE, LINALOOL, BENZYL SALICYLATE, CITRONELLOL.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

    L'BEL
    DERMO CLARITÉ

    brightening and moisturizing facial
    lotion SPF 30

    30 ml e (1 fl.oz.)

    PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    BRIGHTENING AND MOISTURIZING FACIAL SPF 30 
    avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-993
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.03 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.05 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MOTH BEAN (UNII: H7938ON8E5)  
    DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SORBIC ACID (UNII: X045WJ989B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-993-021 in 1 BOX09/26/2016
    1NDC:13537-993-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/26/2016
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-993)
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