Label: TARTEGUARD 30 SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 15, 2021

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  • To Use

    Provides daily hydration & helps protect skin from UVA/UVB rays. Apply prior to sun exposure.

  • Warning

    Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner. Avoid contact with eyes.

  • Medicinal Ingredients

    Zinc Oxide 4.13% w/w, Titanium Dioxide 3.36% w/w

  • Non-medicinal Ingredients

    Eau, 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, tocopherols, glycine soja (soybean) oil, capryloyl glycerin/sebacic acid copolymer, citric acid, triethoxycaprylylsilane, lonicera caprifolium (honeysuckle) flower extract, trisodium ethylenediamine disuccinate, chlorphenesin, fragrance/parfum, 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

    Distr. By tarte™, Inc. NY 10018.

  • PRINCIPAL DISPLAY PANEL - 13 mL Bottle Carton

    tarte
    high-performance naturals™

    TARTEGUARD
    30

    moisturizing sunscreen lotion
    Broad Spectrum UVA/UVB Protection

    SPF 30

    13 mL / 0.4 Fl. Oz

    NPN 8005 6077

    PRINCIPAL DISPLAY PANEL - 13 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:51060-293
    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)  
    COCOYL CAPRYLOCAPRATE (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)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    APPLE (UNII: B423VGH5S9)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    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)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    GERANIOL (UNII: L837108USY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-293-011 in 1 CARTON04/01/2015
    113 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2015
    Labeler - Tarte, Inc. (027905186)
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