Label: CLEAR SMART SHINE CONTROL SUNSCREEN BROAD SPECTRUM SPF 25- avobenzone,homosalate,octisalate,octocrylene cream

  • NDC Code(s): 68828-290-01, 68828-290-02
  • Packager: Jafra Cosmetics International Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 28, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 3% Sunscreen

    Homosalate 10% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 9% Sunscreen

  • 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 useon damaged or broken skin
    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctorif rash occurs

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water-resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours.
    • Children under 6 months of age: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

          • limit your time in the sun, especially from 10 a.m. – 2 p.m.

          • wear long-sleeved shirts, pants, hats, and sunglasses

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Alcohol, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Honey Extract, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lauroyl Lysine, Lecithin, Maltodextrin, Menthyl Lactate, PEG-100 Stearate, Phenethyl Alcohol, Polyester-8, Polysorbate 60, Royal Jelly, Royal Jelly Powder, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45, Water/Aqua, Yeast Extract, Zymomonas Ferment Extract

  • Other information

    Protect this product from excessive heat and direct sun

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    CLEAR SMART SHINE CONTROL SUNSCREEN BROAD SPECTRUM SPF 25 
    avobenzone,homosalate,octisalate,octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-290
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ARGININE (UNII: 94ZLA3W45F)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HONEY (UNII: Y9H1V576FH)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ROYAL JELLY (UNII: L497I37F0C)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-290-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/202009/15/2022
    2NDC:68828-290-0250 mL in 1 TUBE; Type 0: Not a Combination Product03/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/11/2020
    Labeler - Jafra Cosmetics International Inc (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-290)