JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]

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  • JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]

JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]
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NDC 51514-0337-1
Set ID cb91c130-45d4-46a0-9628-50e701a6960c
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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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)**, Magnesium Stearate**, Isopropyl Myristate, Fragrance**, Bisabolol, Iron Oxides (CI 77491)**, Aloe Barbadensis Leaf Juice*, Simmondsia Chinensis (Jojoba) Seed Oil*, Isopropyl Titanium Triisostearate, Iron Oxides (CI 77499)**, Stearalkonium Hectorite, Propylene Carbonate, Laureth-12, Camellia Sinensis (Green Tea) Leaf Extract**, Ethylhexylglycerin, Citric Acid**, Potassium Sorbate**, Sodium Benzoate**.

    * Organic  ** Natural

  • Other Information:

    · Protect this product from excessive heat and direct sun.

  • Principal Display Panel

    60 ml cartonImage components

    Image Components component label

  • INGREDIENTS AND APPEARANCE
    JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0337
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0337-160 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(51514-0337)
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