SUNSCREEN 100 (TITANIUM DIOXIDE) CREAM [CMS LAB INC.]

SUNSCREEN 100 (TITANIUM DIOXIDE) CREAM [CMS LAB INC.]
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NDC 52554-1111-1, 52554-1111-2
Set ID 5bec4efd-2511-e6e1-e053-2a91aa0af4df
Category HUMAN OTC DRUG LABEL
Packager CMS LAB Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Titamiun Dioxdie (2.52%)

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use when skin is red, inflamed, irritated, or painful

    When using this product

    - do not apply on other parts of the body

    - do not use on damaged or broken skin

    - avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

    - do not apply directly to wound or open cut

    Stop use and ask a doctor if

    - Rash or irritation on skin develops and lasts

  • Directions

    - Apply the adequate amount onto the entire face at the last stage of your skin care routine.

    Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips.

    - Apply liberally 15 minutes before sun exposure.

    - Reapply at least every 2 hours.

    - Use a water-resistant sunscreen if swimming or sweating.

    - Children under 6 months of age: ask a doctor

  • Inactive ingredients

    WATER, DIBUTYL ADIPATE, POLYGLYCERYL-2 CAPRATE, SUCROSE STEARATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, STEARIC ACID, ALUMINA, GLYCERYL CAPRYLATE, SQUALANE, GLYCERIN, C12-15 ALKYL BENZOATE, PROPANEDIOL, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, PORTULACA OLERACEA EXTRACT, BUTYLOCTYL SALICYLATE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, ARACHIDYL GLUCOSIDE, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL TRIAZONE, CETEARYL ALCOHOL, SACCHARIDE HYDROLYSATE, SALVIA HISPANICA SEED EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, GLYCERYL STEARATE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL, PANTHENOL, SODIUM STEAROYL GLUTAMATE, POLYACRYLATE CROSSPOLYMER-6, t-BUTYL ALCOHOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, XANTHAN GUM, ETHYLHEXYLGLYCERIN, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, PALMITIC ACID, CHOLESTERYL MACADAMIATE, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN

  • Sunscreen 100

    sunscreen100

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 100 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.26 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SQUALANE (UNII: GW89575KF9)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PURSLANE (UNII: M6S840WXG5)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SACCHARIDE HYDROLYSATE (UNII: ED959S6ACY)  
    CHIA SEED (UNII: NU0OLX06F8)  
    TURMERIC (UNII: 856YO1Z64F)  
    WATER (UNII: 059QF0KO0R)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52554-1111-21 in 1 PACKAGE10/19/2017
    1NDC:52554-1111-150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/19/2017
    Labeler - CMS LAB Inc. (557795012)
    Registrant - CMS LAB Inc. (557795012)
    Establishment
    NameAddressID/FEIBusiness Operations
    CMS LAB Inc.557795012relabel(52554-1111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(52554-1111)

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