Label: MINERAL SUNSCREEN BROAD SPECTRUM SPF 45- zinc oxide and titanium dioxide cream

  • NDC Code(s): 62742-4152-1, 62742-4152-2
  • 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 11, 2017

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

  • ACTIVE INGREDIENT

    Titanium Dioxide - 7.36%

    Zinc Oxide - 5.14%

  • 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

    Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Dimethicone, Glycerin, Polyglyceryl-3 Ricinoleate, Methylpropanediol, Aloe Barbadensis Leaf Juice, Polyhydroxystearic Acid, Aluminum Stearate, Tocopherol, Zinc Stearare, Magnesium Sulfate, Simmondsia Chinesis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Hydrogenated Castor oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ubiquinone, Camellia Oleifera Leaf Extract, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Bisabolol, Panthenol, Tetrahexyldecyl Ascorbate, Carrageenan, Glucose, Myristoyl Pentapeptide-11, Triethoxycaprylylsilane, Alumina, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, Citric Acid, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Mentha Virdis (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, Myritica 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, Geraniol.

  • 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 SPF 45

  • INGREDIENTS AND APPEARANCE
    MINERAL SUNSCREEN BROAD SPECTRUM SPF 45 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION51.4 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE73.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    aloe (UNII: V5VD430YW9)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    UBIQUINONE Q2 (UNII: I7T5V2W47R)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    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 OIL (UNII: AKN3KSD11B)  
    MYRRH OIL (UNII: H74221J5J4)  
    LIME OIL (UNII: UZH29XGA8G)  
    LEMON OIL (UNII: I9GRO824LL)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    TANGERINE (UNII: KH3E3096OO)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    GALBANUM OIL (UNII: 211UF7M8N1)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    VANILLIN (UNII: CHI530446X)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4152-21 in 1 CARTON12/11/2017
    1NDC:62742-4152-140 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/11/2017
    Labeler - Allure Labs, Inc (926831603)
    Registrant - Allure Labs, Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(62742-4152)