Label: LBEL DERMO CLARITE LOCION FACIAL ILUMINADORA HIDRATANTE CON FPS 30 BRIGHTENING AND MOISTURIZING FACIAL SPF 30- avobenzone, octisalate, octocrylene emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 7, 2022

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  • Drug Facts

  • Active Ingredients

    AVOBENZONE 1.80%

    OCTISALATE 4.50%

    OCTOCRYLENE 4.50%

  • Purpose

    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, glycerin, c12-15 alkyl benzoate, butyloctyl salicylate, cyclohexasiloxane, ethylhexyl methoxycrylene, potassium cetyl phosphate, triethylhexanoin, hydrogenated palm glycerides, glyceryl stearate, peg-100 stearate, synthetic fluorphlogopite, hydroxyacetophenone, titanium dioxide, acrylates/c10-30 alkyl acrylate crosspolymer, vigna aconitifolia seed extract, xanthan gum, 1,2-hexanediol, caprylyl glycol, cetearyl isononanoate, sodium cocoyl glutamate, acacia senegal gum, dimethylmethoxy chromanyl palmitate, tetrasodium edta, ceteareth-20, cetearyl alcohol, sodium hydroxide, hydrolyzed algin, ceteareth-12, cetyl palmitate, phenoxyethanol, tin oxide.

  • Company Information

    U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126 Made in Colombia.

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

    www.lbel.com

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    LBEL DERMO CLARITE LOCION FACIAL ILUMINADORA HIDRATANTE CON FPS 30 BRIGHTENING AND MOISTURIZING FACIAL SPF 30 
    avobenzone, octisalate, octocrylene emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE18 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE45 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    MOTH BEAN (UNII: H7938ON8E5)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STANNOUS OXIDE (UNII: JB2MV9I3LS)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    ACACIA (UNII: 5C5403N26O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-315-011 in 1 BOX10/13/2022
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02010/13/2022
    Labeler - BEL STAR S A (880160197)
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