Label: CARECELLA SUN CREAM- amiloxate, ethylhexyl triazone cream

  • NDC Code(s): 69422-1006-1, 69422-1006-2
  • Packager: General Bio Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 8, 2024

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

  • ACTIVE INGREDIENT

    Amiloxate (7.49%) ------------------------------------------------------------------------------- Sunscreen

    Ethylhexyl Triazone (4.5%) -------------------------------------------------------------------- Sunscreen

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps to prevent sunburn

  • WARNINGS

    For external use only.

  • DO NOT USE

    • if you are allergic to any of the ingredients
    • on damaged or broken skin
  • WHEN USING

    • keep out of eyes. Rinse with water to remove.
  • STOP USE

    • rash or irritation develops and lasts.
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    • Apply liberally onto the cleansed entire face and neck 15 minutes prior to sun exposure.
    • Reapply as needed or after towel drying, swimming, or sweating.
    • Reapply at least every 2 hours: “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 time in the sun, especially from 10 a.m. - 2 p.m.; and wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months: Ask a doctor.
  • OTHER SAFETY INFORMATION

    • Store in a cool dry place away from direct sunlight.
    • “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.”
  • INACTIVE INGREDIENT

    Centella Asiatica (Gotu Kola) Leaf Extract, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Butylene Glycol, Propanediol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Dibutyl Adipate, Ethanol, C13-16 Isoalkane, Niacinamde, Water, Silicon Dioxide, Alkyl (C12-15) Benzoate, Dipropylene Glycol, Dicaprylyl Carbonate, Poly C10-30 Alkyl Acrylate, Medium-Chain Triglycerides, Heptyl Undecylenate, Cetostearyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Polyglyceryl-3 Methylglucose Distearate, Candida Bombicola/Glucose/Methyl Rapeseedate Ferment, Glyceryl Monostearate, Oryza Sativa (Rice) Germ Oil, Coconut Oil, Hydrogenated Vegetable Oil, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyacrylate Crosspolymer-6, Docosanol, Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer, Polyisobutylene, Stearic Acid, Caprylyl Glycol, Schisandra Chinensis (Schizandra Berry) Seed Extract, Glycyrrhizinate Dipotassium, Tocopherol, Adenosine, Centella Asiatica (Gotu Kola) Extract, Sunflower Oil, Vincetoxicum Atratum (Swallowwort) Whole Extract, Caprylyl/Capryl Oligoglucoside, Sorbitan Monooleate, Madecassoside, Asiaticoside, t-Butyl Alcohol, Madecassic Acid, Asiatic Acid, Phytosphingosine

  • Carecella Daily Sun Cream

    CaraCella Sun Cream

  • INGREDIENTS AND APPEARANCE
    CARECELLA SUN CREAM 
    amiloxate, ethylhexyl triazone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69422-1006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE7.49 g  in 100 mL
    ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4) ETHYLHEXYL TRIAZONE4.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    ALCOHOL (UNII: 3K9958V90M)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    RICE GERM OIL (UNII: D4H5GGS5JF)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69422-1006-21 in 1 BOX07/19/2023
    1NDC:69422-1006-150 mL in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/19/2023
    Labeler - General Bio Co., Ltd. (695273863)
    Registrant - General Bio Co., Ltd. (695273863)
    Establishment
    NameAddressID/FEIBusiness Operations
    General Bio Co., Ltd.695273863manufacture(69422-1006)