Label: BELO SUN EXPERT TINTED SUNSCREEN- octyl methoxycinnamate, titanium dioxide, octocrylene cream

  • 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 November 29, 2022

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  • Active Ingredients

    Active Ingredients Purpose

    Octyl methoxycinnamate 5% Sunscreen

    Titanium dioxide 6.13%

    Octocrylene .8%

  • Use

    Use

    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 product is swallowed, get Poison Control Center right away.

  • Directions

    • apply liberally 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

    Other Information

    protect the product in this container from excessive heat and direct sun

    • high sun protection product
  • Inactive Ingredients

    Inactive Ingredients

    water, aluminum hydroxide, lauroyl lysine, cyclotetrasiloxane, cyclopentasiloxane, cetyl alcohol, glyceryl stearate, ceteareth-20, ceteraeth-12, cetearyl alcohol, cetyl palmitate, butylene glycol, bee venom, dimethicone, cetearyl dimethicone crosspolymer, methylsisesquioxane resin, niacinamide, alumina, simethicone, ethylhexyl methoxycrylene, avobenzone, butyrospermum parkii, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, sorbitan palmitate, sorbitan olivate, benzyl alcohol, glyceryl caprylate, glyceryl undecylenate, iron oxides lauroyl lysine (CI 77492), fragrance, iron oxides lauroyl lysine (CI 66491), iron oxides lauroyl lysine (CI 77499) bisabolol, tetrasodium EDTA, citric acid

  • Questions or Comments?

    Questions or Comments?

    +63 2 7500 3825 or inquiries@iskincareinc.com

  • Purpose

    Purpose

    Helps prevent sunburn

  • label

    Label

  • INGREDIENTS AND APPEARANCE
    BELO SUN EXPERT TINTED SUNSCREEN 
    octyl methoxycinnamate, titanium dioxide, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82701-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.065 mg  in 50 mg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.4 mg  in 50 mg
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    APIS MELLIFERA VENOM (UNII: 76013O881M)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-80 SORBITAN PALMITATE (UNII: 4NR71FN0IA)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82701-001-0150 mg in 1 TUBE; Type 0: Not a Combination Product06/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02006/20/2022
    Labeler - Intelligent Skin Care Inc. (719667461)
    Registrant - A.M. Rieta Corporation (727672787)
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