RADIANCE CC SPF 30 (ZINC OXIDE) CREAM [DR. J SKINCLINIC, INC.]

RADIANCE CC SPF 30 (ZINC OXIDE) CREAM [DR. J SKINCLINIC, INC.]
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NDC 59189-101-11
Set ID 8ad70ab9-2f77-46df-9882-d502cb6422d7
Category HUMAN OTC DRUG LABEL
Packager DR. J SKINCLINIC, INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Non-Nano Uncoated
    Zinc Oxide (13%)

  • PURPOSE

    SUNSCREEN

  • USES

    HELPS PREVENT SUNBURN.

  • 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 or irritation occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    If swallowed, get medical help or contact Poison Control Center immediately.

  • DIRECTIONS:

    Shake well for several seconds, then apply liberally over the face and neck 15 minutes prior to sun exposure.

  • INACTIVE INGREDIENTS:

    *(Decolorized) Aloe Barbadensis (Aloe Vera) Leaf Juice, *Rubus Ursinus (California Blackberry) Fruit, *Actinidia Chinensis (California Kiwi) Fruit, *Punica Granatum (California Pomegranate) Fruit, *Vitis Vinifera (California Grapes) Fruit, *Simmondsia Chinensis (Jojoba) Seed Oil, *Argania Spinosa (Argan) Kernel Oil, *Borago Officinalis (Borage) Seed Oil, *Vaccinium Macrocarpon (Cranberry) Seed Oil, *Rosa Canina (Rosehip) Fruit Oil, Tocopherol, *Rubus Idaeus (Raspberry) Seed Oil, *Carthamus Tinctorius (Safflower) Seed Oil, *Cocos Nucifera (Coconut) Oil, Glycerin, CI 77492,CI 77491, CI 77499, CI 77891, *Tapioca Starch, Silica, Benzyl Alcohol,Glyceryl Caprylate, Glyceryl Undecylenate, Sodium Benzoate, Potassium Sorbate, Limonene, Linalool, Fragrance (Natural Parfum)

    *organic

    Dermatology tested.

  • PRINCIPAL DISPLAY PANEL

    CC Cream SPF-30

  • INGREDIENTS AND APPEARANCE
    RADIANCE CC  SPF 30
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59189-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    RUBUS URSINUS WHOLE (UNII: EB3AN7DKSL)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    GRAPE (UNII: 6X543N684K)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BORAGE OIL (UNII: F8XAG1755S)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59189-101-1150 mL in 1 TUBE; Type 0: Not a Combination Product02/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/02/2019
    Labeler - DR. J SKINCLINIC, INC. (101497332)
    Establishment
    NameAddressID/FEIBusiness Operations
    MICRO CONNECTION ENTERPRISES, INC., THE144297160pack(59189-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    DR. J SKINCLINIC, INC.101497332manufacture(59189-101)

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