Label: CARECELLA DAILY SUN CREAM- avobenzone, homosalate, octocrylene, octinoxate, octisalate, titanium dioxide cream

  • NDC Code(s): 69422-1004-1, 69422-1004-2
  • Packager: General Bio Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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

  • ACTIVE INGREDIENT

    Avobenzone (2.97%) ------------------------------------------------------------------------------- Sunscreen

    Homosalate (7.5%) --------------------------------------------------------------------------------- Sunscreen

    Octocrylene (7.5%) --------------------------------------------------------------------------------- Sunscreen

    Octyl Methoxycinnamate (7.0%) ---------------------------------------------------------------- Sunscreen

    Octyl Salicylate (5.0%) ---------------------------------------------------------------------------- Sunscreen

    Titanium Dioxide (5.3%) -------------------------------------------------------------------------- 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

    1,2-Hexanediol, Caprylyl/Capryl Oligoglucoside, Acetyl Hexapeptide-8, Adenosine, Allantoin, Aloe Vera (Aloe Barbadensis) Leaf Juice, Arginine, Artemisia Vulgaris Top Oil, Bergamot Oil, Butylene Glycol, C13-15 Alkane, Caprylyl/Capryl Oligoglucoside, Caprylyl Glycol, Centella Asiatica Extract, Chamaemelum Nobile (Anthemis Nobilis) Flower Oil, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dipropylene Glycol, Edetate Sodium, Ethyl Ferulate, Glycerin, Glyceryl Monostearate, Hexapeptide-9, Hydroxyacetophenone, Lavender Oil, Niacinamide, Octinoxate, Octisalate, Orange (Citrus Aurantium Dulcis) Peel Oil Palmarosa Oil, Polyisobutylene, Polyglyceryl-10 Laurate, Polyglyceryl-2 Oleate, Polyglyceryl-2 Stearate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-5 Trioleate, Polyhydroxystearic Acid, Polyisobutylene, Prezatide, Prezatide Copper, Propanediol, Rosa Rugosa Flower Bud Oil, Rosemary (Rosmarinus Officinalis) Leaf Extract, Silicon Dioxide, Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer, Sorbitan Isostearate, Sorbitan Monooleate, Succinoglycan, Sunflower (Helianthus Annuus) Seed Oil, Tocopherol, Triethoxycaprylylsilane, Tripeptide-3, Uridine Monophosphate Disodium, Water, Yellow Wax

  • Carecella Daily Sun Cream

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  • INGREDIENTS AND APPEARANCE
    CARECELLA DAILY SUN CREAM 
    avobenzone, homosalate, octocrylene, octinoxate, octisalate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69422-1004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.3 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.97 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    HEXAPEPTIDE-9 (UNII: L25414IE41)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)  
    POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ARGININE (UNII: 94ZLA3W45F)  
    POLYGLYCERYL-5 TRIOLEATE (UNII: SZ1T9D7ZKX)  
    ADENOSINE (UNII: K72T3FS567)  
    ROSEMARY (UNII: IJ67X351P9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARTEMISIA VULGARIS TOP OIL (UNII: 72Q967Y48V)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    PREZATIDE (UNII: 39TG2H631E)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)  
    WATER (UNII: 059QF0KO0R)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69422-1004-21 in 1 BOX10/07/2020
    1NDC:69422-1004-150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/07/2020
    Labeler - General Bio Co., Ltd. (695273863)
    Registrant - General Bio Co., Ltd. (695273863)
    Establishment
    NameAddressID/FEIBusiness Operations
    General Bio Co., Ltd.695273863manufacture(69422-1004)