Label: MINERAL SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 20- zinc oxide and titanium dioxide cream

  • NDC Code(s): 62742-4153-1, 62742-4153-2
  • Packager: Allure Labs, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 12, 2017

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

  • ACTIVE INGREDIENT

    Titanium Dioxide - 4.80%

    Zinc Oxide - 5.00%

  • INDICATIONS & USAGE

    Helps prevent sunburn

    if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    For external use only.

  • DO NOT USE

    do not use on damaged or broken skin.

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    if product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    apply liberally 15 minutes before sun exposure.

    use a water resistant sunscreen if swimming or sweating.

    reapply:

    immidiately aftr swimming, sweating or towel drying.

    at least every 2 hours.

    children under 6months: ask doctor

    Sun protection measures:

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protector measures including:

    limit time in the sun, especially from 10:00 am to 2:00 pm.

    wear long sleaved shirts, pants, hats and sun glasses.

  • OTHER SAFETY INFORMATION

    May stain or damage some fabrics or surfaces. Avoid long term storage above 40C (120F). Protect the product in this container from excessive heat and direct sunlight.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Polyhydroxysteari Acid, Vitis Vinifera (Grape) Seed Oil, Sodium Stearoyl Glutamate, Glyceryl Stearate, Cetearyl Glucoside, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Pichia/Resveratrol Ferment Extract, Malus Domestica Fruit Cell Culture Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Hyaluronate, Carrageenan, Glucose, Tocopherol, Myristoyl Pentapeptide-11, Bisabolol, Benzylidene Dimethoxydimethylindanone, Tetrahydrodiferuloylmethane, Glyceryl Isostearate, Water (Aqua), Aluminum Stearate, Alumina, Microcrystalline Cellulose, Cellulose Gum, Phenoxyethanol, Xanthan Gum, Ethylhexylglycerin, Caprylyl Glycol, Lecithin, Citric Acid, Disodium EDTA, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Fusanus Spicatus Wood Oil, Salvia Sclarea (Clary) Oil, Rosa Damascena Flower Oil, Mentha Piperita (Peppermint) Oil, Citrus Reticulata (Tangerine) Leaf Oil, Pogostemon Cablin Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Commiphora Myrrha Oil, Citrus Aurantifolia (Lime) Oil, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Grandis (Grapefruit) Peel Oil, Abies Sibirica Oil, Eucalyptus Globulus Leaf Oil, Juniperus Virginiana Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Citrus Nobilis (Mandarin Orange) Peel Oil, Pelargonium Graveolens Flower Oil, Ferula Galbaniflua (Galbanum) Resin Oil, Triethyl Citrate, Vanillin, Ethyl Vanillin, Limonene, Linalool, Benzyl Alcohol, Feraniol, Citronellol.

  • PRINCIPAL DISPLAY PANEL

    Distributed By:

    The Soleil Group, LLC.

    Bronxville, NY 10708

    Energie 43

    1271 EC Huizen, Netherlands

    www.soleiltoujours.com

    MADE IN U.S.A.

    Image Mineral BS SPF 20

  • INGREDIENTS AND APPEARANCE
    MINERAL SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 20 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50.0 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE48.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    MALUS DOMESTICA FLOWER (UNII: EF626V855K)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
    TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)  
    PATCHOULI OIL (UNII: F3IN55X5PO)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    MYRRH OIL (UNII: H74221J5J4)  
    LIME OIL (UNII: UZH29XGA8G)  
    LEMON OIL (UNII: I9GRO824LL)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    MANDARIN OIL (UNII: NJO720F72R)  
    GALBANUM OIL (UNII: 211UF7M8N1)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    VANILLIN (UNII: CHI530446X)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    LIMONENE OXIDE, (+)- (UNII: 278IM94GXB)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GERANIOL (UNII: L837108USY)  
    CITRONELLOL ACETATE, (R)- (UNII: 9X45FJL446)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4153-21 in 1 CARTON12/12/2017
    1NDC:62742-4153-140 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/12/2017
    Labeler - Allure Labs, Inc (926831603)
    Registrant - Allure Labs, Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(62742-4153)