Label: GODDESS GARDEN ORGANICS SUNNY BODY NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT  - titanium dioxide and zinc oxide lotion 

  • NDC Code(s): 58479-005-00, 58479-005-01
  • Packager: Crossing Cultures, LLC dba Goddess Garden
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/13

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

  • GODDESS GARDEN ORGANICS Sunny Body NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT
  • Active Ingredients

    Titanium Dioxide 6.4%  Zinc Oxide 6.0%

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  • Purpose

    Sunscreen

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  • Uses

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

    • For external use only.

    • Do not use

    on damaged or broken skin.

    • Stop use and ask a doctor

    if rash occurs.

    • When using this product

    keep out of eyes. Rinse with water to remove.

    • Keep out of reach of children.

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

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  • Directions

    • Apply liberally 15 minutes before 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 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 10am to 2pm.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
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  • Inactive Ingredients

    Aloe Vera*, Cetyl Alcohol, Butyrospermum Parkii (Shea Butter) Seed Oil*, Gluconolactone, Glycerin*, Glyceryl Stearate, Glycine Soja (Soybean) Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Lavandula Angustifolia (Lavender) Oil, Ionicera Caprifolium (Honeysuckle) Extract, Ionicera Japonica (Honeysuckle) Flower Extract, Polyhydroxystearic Acid, Populus Tremuloides (Aspen) Bark Extract, Radish Root Ferment Filtrate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum
    *Certified Organic

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  • Other information

    • Protect this product from excessive heat and direct sun.
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  • Questions or Comments

    Toll-free 1-855-SAFE-SUN or www.GoddessGarden.com

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  • Sheer Mineral Lotion

    Enjoy happy, carefree days in the sun! Goddess Garden Natural Sunscreen is safe and effective and made with organic ingredients Created by a mom for her daughter, our products are free of chemical sunscreens, biodegradable and sheer.

    Have a sunny day!  Nova Covington, Founder

    Sheer Mineral Lotion - Free of Chemical Sunscreens - Biodegradable Cruelty Free - Reef Safe - Non-GMO

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  • PRINCIPAL DISPLAY PANEL

    GODDESS GARDEN
    ORGANICS

    Sunny Body
    NATURAL SUNSCREEN  30

    92% ORGANIC
    INGREDIENTS

    ECO SHEER  SUN SAFE

    BROAD SPECTRUM SPF 30
    WATER RESISTANT (40 MINUTES)

    Powerful Mineral Protection
    6oz/177ml

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  • GODDESS GARDEN ORGANICS Sunny Body NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT 100ml (58479-005-00)| GODDESS GARDEN ORGANICS Sunny Body NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT 177ml (58479-005-01)
  • INGREDIENTS AND APPEARANCE
    GODDESS GARDEN ORGANICS SUNNY BODY NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT  
    titanium dioxide, zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58479-005
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 64 mg  in 1 mL
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 60 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    CETYL ALCOHOL  
    SHEANUT OIL  
    GLUCONOLACTONE  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    SOYBEAN OIL  
    SUNFLOWER OIL  
    LAVENDER OIL  
    STEARIC ACID  
    TOCOPHEROL  
    XANTHAN GUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58479-005-00 1 in 1 CARTON
    1 100 mL in 1 TUBE
    2 NDC:58479-005-01 1 in 1 CARTON
    2 177 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/24/2013
    Labeler - Crossing Cultures, LLC dba Goddess Garden (078444606)
    Establishment
    Name Address ID/FEI Business Operations
    Crossing Cultures, LLC dba Goddess Garden 078444606 manufacture(58479-005)
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