Label: RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide lotion

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

Drug Label Information

Updated December 13, 2024

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

  • Drug Facts

  • Active ingredient

    Zinc Oxide 18%

  • Purpose

    Sunscreen

  • Uses

    •  Helps prevent sunburn.

    •  If used as directed with other sun protection measures (see Directions), decreases the risk of 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 doctor if rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Apply liberally and evenly 15 minutes prior to sun exposure

    • Reapply: After 40 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 a.m. - 2 p.m.

    •  Wear long-sleeved shirts, pants, hats, and sunglasses.

  • Other information

    • Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, helianthus annuus (sunflower) seed

    oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl

    alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis

    leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit

    extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate.

  • Questions?

    Call us! (702) 275-6167

  • SPL UNCLASSIFIED SECTION

    REEF SAFE

    NON-NANO

    BORN ON MAUI

    MADE IN USA

    Save your skin 

    Save our reefs

    TSA Friendly

    Fragrance Free

    Distributed by: Formula 7venz, LLC.

    118 Kupuohi Street Suite C-4

    Lahaina, HI 96761

    redgeckosunscreen.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82086-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    RICE BRAN (UNII: R60QEP13IC)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SQUALANE (UNII: GW89575KF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82086-002-34100 mL in 1 TUBE; Type 0: Not a Combination Product07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/02/2020
    Labeler - Formula 7venz L.L.C. (118069729)