Label: TRIPLE DEFENSE SUNSCREEN BROAD SPECTRUM SPF 40- sunscreen 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 November 13, 2020

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  • Active Ingredients

    Titanium Dioxide 3.3%

    Zinc Oxide 8.8%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides high protection against sunburn
  • Warnings

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash or irritation develops and lasts.

    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

    o Immediately after towel drying

    o At least every 2 hours

    • Children under 6 months of age: ask a doctor

    • 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 am to 2 pm

    • wear long-sleeved shirts, pants, hats and sunglasses

  • Other Information

    Protect this product from excessive heat and direct sun

  • Inactive Ingredients

    Alkyl (C12-15) Benzoate, Alpha Lipoic Acid, Artemisia Capillaris Flower, Butylene Glycol, Caprylyl Glycol, Chia Seed, Cyclomethicone, Diatomaceous Earth, Dimethicone, Dunaliella Salina, Ethylhexylglycerin, Fragrance, Glycerin, Haematococcus Pluvialis, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Galactoarabinan, Green Tea Leaf, Karum Seed Oil, Mannitol, Matricaria Chamomilla Whole, Oleth-10, Phenoxyethanol, Phymatolithon Calcareum, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid (2300 MW), Polysorbate 20, Polysorbate 60, Propanediol, Propanediol Dicaprylate, Silicon Dioxide, Sodium Phosphate, Sorbitol, Tetrahexyldecyl Ascorbate, Trehalose, Triethoxycaprylylsilane, Water, Xylitol, Zinc Sulfate

  • Tube and Carton label

    Caron LabelTube Label

  • INGREDIENTS AND APPEARANCE
    TRIPLE DEFENSE SUNSCREEN BROAD SPECTRUM SPF 40 
    sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73040-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE88 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE33 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    TREHALOSE (UNII: B8WCK70T7I)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPANEDIOL DICAPRYLATE (UNII: C577OMC6UH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MANNITOL (UNII: 3OWL53L36A)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    OLETH-10 (UNII: JD797EF70J)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ARTEMISIA CAPILLARIS FLOWER (UNII: KG4724BPZG)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)  
    CHIA SEED (UNII: NU0OLX06F8)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73040-001-011 in 1 CARTON11/13/2020
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/13/2020
    Labeler - Rothschild Beauty Group LLC (062783354)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAKA USA Inc. dba Cosmetic Innovations802860515manufacture(73040-001)
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