TARTEGUARD 30 SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [TARTE, INC]

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  • TARTEGUARD 30 SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [TARTE, INC]

TARTEGUARD 30 SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [TARTE, INC]
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NDC 51060-015-04
Set ID 4a742b5e-c0d6-4e00-a1c4-e83a20aa1554
Category HUMAN OTC DRUG LABEL
Packager Tarte, Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 3.36%Sunscreen
    Zinc Oxide 4.13%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.

    Stop use and ask doctor if rash occurs.

    Do not use on damaged or broken skin.

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

    Keep out of the reach of children. If 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.
    • Apply to all skin exposed to the sun.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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 10 a.m.-2 p.m.
      –
      Wear long-sleeved shirts, pants, hats and sunglasses
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
    • You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.
  • Inactive ingredients

    Water, butyloctyl salicylate, coco-caprylate/caprate, C12-15 alkyl benzoate, caprylic/capric triglyceride, diheptyl succinate, polyglyceryl-6 distearate, propanediol, jojoba esters, glycerin, pyrus malus (apple) fruit extract, polysorbate 20, polyhydroxystearic acid, polymethylsilsesquioxane, potassium cetyl phosphate, phenoxyethanol, alumina, diethylhexyl syringylidenemalonate, xanthan gum, tocopherol, glycine soja (soybean) oil, capryloyl glycerin/sebacic acid copolymer, citric acid, triethoxycaprylylsilane, lonicera caprifolium (honeysuckle) flower extract, trisodium ethylenediamine disuccinate, chlorphenesin, fragrance, stearic acid, ethylhexylglycerin, passiflora edulis seed oil, lonicera japonica (honeysuckle) flower extract, algae extract, pseudoalteromonas exopolysaccharides, sodium hyaluronate, sodium salicylate, propylene glycol, sodium dehydroacetate.

  • SPL UNCLASSIFIED SECTION

    Dist. by tarte™, Inc. NY 10018.

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    RECOMMENDED
    SKIN
    CANCER
    FOUNDATION
    DAILY USE

    tarte
    high-performance naturals™

    TARTEGUARD
    30

    sunscreen lotion
    Broad Spectrum SPF 30

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TARTEGUARD 30 SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide33.6 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide41.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    butyloctyl salicylate (UNII: 2EH13UN8D3)  
    coco-caprylate/caprate (UNII: 8D9H4QU99H)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    diheptyl succinate (UNII: 057N7SS26Y)  
    polyglyceryl-6 distearate (UNII: Z35I17EQOP)  
    propanediol (UNII: 5965N8W85T)  
    glycerin (UNII: PDC6A3C0OX)  
    apple (UNII: B423VGH5S9)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    aluminum oxide (UNII: LMI26O6933)  
    diethylhexyl syringylidenemalonate (UNII: 3V5U97P248)  
    xanthan gum (UNII: TTV12P4NEE)  
    tocopherol (UNII: R0ZB2556P8)  
    soybean oil (UNII: 241ATL177A)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    lonicera caprifolium flower (UNII: 5N1WD9784U)  
    trisodium ethylenediamine disuccinate (UNII: YA22H34H9Q)  
    chlorphenesin (UNII: I670DAL4SZ)  
    stearic acid (UNII: 4ELV7Z65AP)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    passiflora edulis seed oil (UNII: F3VOA31UHQ)  
    lonicera japonica flower (UNII: 4465L2WS4Y)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    sodium salicylate (UNII: WIQ1H85SYP)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    polyhydroxystearic acid (2300 MW) (UNII: YXH47AOU0F)  
    jojoba oil (UNII: 724GKU717M)  
    polymethylsilsesquioxane (11 microns) (UNII: Z570VEV8XK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-015-041 in 1 CARTON04/01/2015
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/01/2015
    Labeler - Tarte, Inc (027905186)
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