Label: JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT RADIANCE- zinc oxide, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 October 8, 2019

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  • BOXED WARNING (What is this?)

    Drug Facts

  • Active Ingredients

    Zinc Oxide 9.4%**

    Titanium Dioxide 5.9%**

  • Purpose

    Sunscreen

    Sunscreen

  • Uses

    · Helps prevent sunburn

    · If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    For external use only

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product

    · keep out of eyes

    · Rinse with water to remove

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • apply liberally 15 minutes before sun exposure

    • use a water resistant sunscreen if swimming or sweating

    • reapply at least every 2 hours

    • children under 6 months: Ask a doctor

  • WHEN USING

    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 protection measures including:

    • Limit time in the sun, especially from 10am - 2pm.

    • Wear long-sleeve shirts, pants, hats, and sunglasses

  • Inactive Ingredients:

    Aqua (Water)**, Caprylic/Capric Triglyceride**, Ethylhexyl Palmitate**, Titanium Dioxide**, Cyclopentasiloxane, Argania Spinosa (Argan) Kernel Oil**, Polyglyceryl-6 Polyricinoleate**, Mica**, Nylon-12, Glycerin**, Polyhydroxystearic Acid, Polyglyceryl-2 Isostearate, Methicone, Alumina, Phenoxyethanol, Isononyl Isononanoate, Disteardimonium Hectorite, Tocopheryl Acetate, Triethoxycaprylylsilane, Polysilicone-11, Sodium Chloride**, Iron Oxide (CI 77492)**, Bismuth Oxychloride, Magnesium Stearate**, Isopropyl Myristate, Fragrance**, Bisabolol, Iron Oxides (CI 77491)**, Cochineal, Aloe Barbadensis Leaf Juice*, Simmondsia Chinensis (Jojoba) Seed Oil*, Tin oxide (CI 77861)**, Isopropyl Titanium Triisostearate, Iron Oxides (CI 77499)**, Stearalkonium Hectorite, Propylene Carbonate, Laureth-12, Camellia Sinensis (Green Tea) Leaf Extract**, Tocopherol**, Ethylhexylglycerin, Citric Acid**, Potassium Sorbate**, Sodium Benzoate**.

    * Organic ** Natural

  • Other Information:

    · Protect this product from excessive heat and direct sun.

  • Principle Display Panel

    120 ml primary120 ml carton15 ml primary177 ml carton60 ml carton177 ml primary15 ml carton60 ml primary

  • INGREDIENTS AND APPEARANCE
    JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT RADIANCE 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0355
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.4 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.9 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X)  
    MICA (UNII: V8A1AW0880)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    NYLON-12 (UNII: 446U8J075B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    APRICOT (UNII: 269CJD5GZ9)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    LAURETH-12 (UNII: OAH19558U1)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    FARNESOL (UNII: EB41QIU6JL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0355-160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/24/2014
    2NDC:51514-0355-2120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/24/2014
    3NDC:51514-0355-315 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/24/2014
    4NDC:51514-0355-4177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/24/2014
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0355)
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