Label: CLARINS BROAD SPECTRUM SPF 50 SUNSCREEN BODY- avobenzone, homosalate, octinoxate, octisalate, cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Drug facts

  • Active ingredients

    AVOBENZONE 3%,

    HOMOSALATE 10%,

    OCTINOXATE 7.5%,

    OCTISALATE 5%,

    OCTOCRYLENE 10%

    Purpose

    Sunscreen

  • Uses:

    • helps prevent sunburn • if used as directed with other sun protection measures (see

    Directions)

    , decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings:

    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 medical help or contact a Poison Control Center right away.

  • Directions:

    • apply liberally 15 minutes before sun exposure • apply to all skin exposed to the sun • children under 6 months: Ask a doctor

    • Sun Protection Measures.

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating

  • Other information:

    • protect this product from excessive heat and direct sun

  • Questions or comments?

    Call 1-866-325-2746 Monday-Friday 9am to 6:30pm ET

  • Inactive ingredients

    AQUA/WATER/EAU . BUTYLOCTYL SALICYLATE . STYRENE/ACRYLATES COPOLYMER . BUTYLENE GLYCOL . POLYGLYCERYL-6 STEARATE . POLYESTER-7 . NEOPENTYL GLYCOL DIHEPTANOATE . ALOE BARBADENSIS LEAF JUICE . DIETHYLHEXYL SYRINGYLIDENEMALONATE . PARFUM/FRAGRANCE . POLYSILICONE-15 . MANNITOL . POTASSIUM CETYL PHOSPHATE . PHENOXYETHANOL . PEG-8 LAURATE . DIMETHICONE . GLYCERIN . POLYGLYCERYL- 6 BEHENATE . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . POLYACRYLATE CROSSPOLYMER-6 . SODIUM DEHYDROACETATE . CAPRYLIC/CAPRIC TRIGLYCERIDE . TOCOPHEROL . DIMETHICONOL . CYCLODEXTRIN . PISUM SATIVUM (PEA) EXTRACT . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/EXTRAIT DE LEVURE . DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . BHT . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . T-BUTYL ALCOHOL . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE. [S2031C]

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    CLARINS BROAD SPECTRUM SPF 50 SUNSCREEN BODY 
    avobenzone, homosalate, octinoxate, octisalate, cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-9922
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STYRENE (UNII: 44LJ2U959V)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    MANNITOL (UNII: 3OWL53L36A)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CYCLODEXTRINS (UNII: 7E6SK9QDT8)  
    PEA (UNII: W4X7H8GYFM)  
    SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    PLATANUS OCCIDENTALIS BARK (UNII: 85RMN3QGSE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58668-9922-1150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2024
    Labeler - Laboratoires Clarins (266317555)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!