Label: DAILY DEFENDER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT (80 MINUTES)- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 14, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 19.0%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk Skin cancer and early skin aging caused by the sun.
  • 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 occurs.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    For sunscreen use:

    • Apply liberally 15 minutes before sun exposure.
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • 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. - 2 pm.
      • Wear long-sleeved shirts, pants, and sunglasses.
  • Other information

    • Protect this product in this container from excessive heat and direct sun.
  • Questions?

    Call (888) 804-4318 or visit www.thrivecausemetics.com

  • Inactive ingredients

    AQUA/WATER/EAU, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIISOOCTYL SUCCINATE, PROPANEDIOL, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, NIACINAMIDE, GLYCERIN, ETHYLHEXYL METHOXYCRYLENE, POLYMETHYLSILSESQUIOXANE, CETEARYL OLIVATE, MAGNESIUM ALUMINUM SILICATE, POLYHYDROXYSTEARIC ACID, TERMINALIA FERDINANDIANA FRUIT EXTRACT, VACCINIUM VITIS-IDAEA FRUIT EXTRACT, PONGAMIA PINNATA SEED EXTRACT, MALEATED SOYBEAN OIL GLYCERYL/OCTYLDODECANOL ESTERS, ECTOIN, ALOE BARBADENSIS LEAF JUICE, SODIUM HYALURONATE, ASCORBYL TETRAISOPALMITATE, MENTHYL LACTATE, JOJOBA ESTERS, TRIETHOXYCAPRYLYLSILANE, ARACHIDYL ALCOHOL, SILICA, LAUROYL LYSINE, POTASSIUM CETYL PHOSPHATE, POLYGLYCERYL-4 LAURATE/SUCCINATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISONONYL ISONONANOATE, OCTYLDODECANOL, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, POLYGLUTAMIC ACID, SORBITAN OLEATE, TRIHYDROXYSTEARIN, ARACHIDYL GLUCOSIDE, SORBITAN OLIVATE, BEHENYL ALCOHOL, XANTHAN GUM, GLUCONOLACTONE, CALCIUM GLUCONATE, TETRASODIUM GLUTAMATE DIACETATE, CITRIC ACID, SODIUM BENZOATE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, PHENOXYETHANOL, [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)].

  • SPL UNCLASSIFIED SECTION

    Dist. by Thrive Causemetics, Inc.
    Los Angeles, CA 90045

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

    bigger
    than
    beauty®
    SKINCARE

    DERMATOLOGIST
    RECOMMENDED

    DAILY DEFENDER™

    MINERAL
    SUNSCREEN

    Broad Spectrum SPF 50

    Barrier Power Boost™

    Water Resistant (80 minutes)

    UNTINTED

    1.7 fl oz / 50 mL

    Principal Display Panel - 50 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    DAILY DEFENDER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT (80 MINUTES) 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77365-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION190 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIISOBUTYL SUCCINATE (UNII: 1241X4J800)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    LINGONBERRY (UNII: 0UNK9RZQ7X)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    SOYBEAN OIL GLYCERETH-8 ESTERS (UNII: 8Y338J838M)  
    ECTOINE (UNII: 7GXZ3858RY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POLYGLYCERYL-4 LAURATE/SUCCINATE (UNII: KAB6DS9SBS)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) (UNII: H58HX2GWJ5)  
    POLYGLUTAMIC ACID (8000 MW) (UNII: D4JEG46UXV)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77365-009-011 in 1 BOX08/12/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02008/12/2024
    Labeler - Thrive Causemetics (039299574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Solutions, LLC807907928MANUFACTURE(77365-009)