Label: CC CREAM SPF 30- zinc oxide, titanium dioxide cream

  • NDC Code(s): 79489-0010-0
  • Packager: HAN Skin Care Cosmetics, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 9, 2020

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

  • Drug Facts

  • Active Ingredients(in each 30 ml)

    Zinc Oxide 21%

    Titanium Dioxide 6%

    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 develops and lasts.

    Keep out of reach of children.

    If swallowed, call a poison control center or get medical help right  away.

  • Directions

    • Apply daily, alone or under makeup.
    • Apply liberally 15 minutes before sun exposure and as needed.
    • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing.
    • Use water resistant sunscreen if swimming or sweating.
    • Sun Protecion 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 spectum SPF of 15 or higher and other sun protection measure including: limiting time in the sun, especially from 10am-2pm; wearing long sleeve shirts, pants and sunglasses.
    • Children under 6 months: ask a doctor.
  • Inactive Ingredients

    Coconut Alkanes, Cocos Nucifera (Virgin Coconut) Oil, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Ricinus Communis (Castor) Seed Oil*, Ethyl Macadamiate, Shea Butter Ethyl Ester, Glycerin*, Polyglyceryl Esters, Polyhydroxystearic Acid, Citrus Aurantium Dulcis (Orange) Peel Wax, Simmondsia Chinensis (Jojoba) Seed Oil*, Jojoba Esters, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter) Fruit*, Tocopherol (Vitamin E), Capric Acid, Silica, Disteardimonium Hectorite, Kaolin, Argania Spinosa (Argan) Kernel Oil, Rosa Canina Seed (Rosehip) Oil, Lavandula Angustifolia (Lavender) Oil, Olea Europaea (Olive) Oil, Origanum Vulgare (Oregano) Leaf Extract,
    Tocopheryl Acetate, Basabolol, Malic Acid. May Contain: Iron Oxides.
    *Certified Organic

  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Package Labeling

    Bottle

  • INGREDIENTS AND APPEARANCE
    CC CREAM SPF 30 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79489-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION210 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TRICAPRILIN (UNII: 6P92858988)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAPRIC ACID (UNII: 4G9EDB6V73)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    OREGANO (UNII: 0E5AT8T16U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MALIC ACID (UNII: 817L1N4CKP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79489-0010-01 in 1 BOX07/01/2020
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2020
    Labeler - HAN Skin Care Cosmetics, LLC (039398075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Columbia Cosmetics Manufacturing, Inc.068267863manufacture(79489-0010)