Label: GREEN DEFENSE BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

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

Drug Label Information

Updated October 28, 2023

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

  • Drug Facts

  • ACTIVE INGREDIENTS

    Titanium Dioxide 2.40%

    Zinc Oxide 5.82%

    Purpose

    Sunscreen

  • Uses

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

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    •  Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measure.
    • 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: Ask a doctor
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
    • You may report a serious adverse event from use of this product to: 1-844-432-7622 Farmacy Beauty LLC. 1111 MacArthur Blvd. Mahwah NJ 07430
  • Inactive ingredients

    Water (Aqua), Ethyl Macadamiate, Cyclopentasiloxane, Ethylhexyl Palmitate, C12-15 Alkyl Benzoate, Propanediol, Polysorbate 80, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Polyglyceryl-6 Isostearate, Dimethicone, Echinacea Purpurea Root Extract, Aronia Melanocarpa Fruit Extract, Hydrolyzed Verbascum Thapsus Flower, Tagetes Erecta Flower Extract, Alteromonas Ferment Extract, Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Malic Acid, Tocopherol, Myristic Acid, Glycerin, Hydrogenated Lecithin, Panthenol, Stearic Acid, Microcrystalline Cellulose, Alumina, Behenic Acid, stearyl Alcohol, Carprylyl Methicone, Cyclohexasiloxane, Isohexadecane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Beheny Alcohol, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, sorbitan Oleate, Butylene Glycol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Sodium Benzoate, Potassium Sorbate, Sodium Citrate, Citric Acid, Sodium Phytate

  • Package Labeling:

    BottleBottle2

  • INGREDIENTS AND APPEARANCE
    GREEN DEFENSE BROAD SPECTRUM SPF 30 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72830-261
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE24 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION58.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYGLYCERYL-6 ISOSTEARATE (UNII: 5VKGO1O03G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
    ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)  
    TAGETES ERECTA FLOWER (UNII: UH5X33P33E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    MALIC ACID (UNII: 817L1N4CKP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72830-261-5050 mL in 1 TUBE; Type 0: Not a Combination Product05/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/31/2020
    Labeler - Farmacy (081343430)