Label: SOLAR DEFENSE TINTED- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Titanium Dioxide (2.5%)

    Zinc Oxide (6%)

    Purpose

    Sunscreen

  • Uses

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

    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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months of age: Ask a doctor
  • Inactive Ingredients

    1,2-Hexanediol, Acrylates/Ammonium Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Alpinia Galanga Extract, Alumina, Benzyl Benzoate, Benzyl Salicylate, Biotin, Boron Nitridem, Butylene Glycol, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cellulose Acetate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citral, Citric Acid Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclophentasiloxane, Dimethicone , Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Hexyl Cinnamal, Hydrolyzed Yeast Protein, Hydroxyethyl Acylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Lilial, Limonene, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol Stearate, Propylene Glycol, Pyridoxine HCl, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Water, Xanthan Gum

  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • Questions or comments?

    Call 1.800.932.9873

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    SOLAR DEFENSE TINTED 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60934-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE25 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BIOTIN (UNII: 6SO6U10H04)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CITRAL (UNII: T7EU0O9VPP)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ACAI (UNII: 46AM2VJ0AW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60934-005-011 in 1 BOX01/11/2017
    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 DrugM02001/11/2017
    Labeler - HydroPeptide LLC (006297465)