Label: GOONG SECRET MILD SUN SPF25 PA PLUS PLUS- zinc oxide and titanium dioxide cream 

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  • 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 04/13

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  • ACTIVE INGREDIENT

    Active Ingredients: Zinc Oxide 4.7%, Titanium Dioxide 3.3%

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  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Cyclopentasiloxane, Ethylhexyl Palmitate, Cyclohexasiloxane, PEG-10 Dimethicone, Butylene Glycol, Glycerin, Neopentyl Glycol Diheptanoate, Caprylyl Methicone, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Pentylene Glycol, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sorbitan Sesquioleate, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Alumina, Stearic Acid, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Opuntia Coccinellifera Fruit Extract, Olea Europaea (Olive) Fruit Oil, Prunus Persica (Peach) Leaf Extract, Bambusa Vulgaris Leaf/Stem Extract, Prunus Mume Flower Extract, Artemisia Princeps Leaf Extract, Angelica Acutiloba Root Extract, Paeonia Albiflora Root Extract, Cnidium Officinale Root Extract, Gardenia Florida Fruit Extract, Schizonepeta Tenuifolia Extract, Salix Alba (Willow) Bark Extract, Scutellaria Baicalensis Root Extract, Sophora Japonica Root Extract, Morus Alba Stem Extract, Fraxinus Excelsior Bark Extract, Citrus Aurantium Dulcis (Orange) Oil, Disodium EDTA, Citrus Grandis (Grapefruit) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Cedrus Atlantica Bark Oil, Camellia Japonica Seed Oil, Sodium Hyaluronate, Butyrospermum Parkii (Shea) Butter, Betula Platyphylla Japonica Juice, Pelargonium Graveolens Flower Oil, Glyceryl Caprylate, Copaifera Officinalis (Balsam Copaiba) Resin, Jasminum Officinale (Jasmine) Oil, Ceramide 3, Illicium Verum (Anise) Fruit/Seed Oil, Artemisia Absinthium Extract, Rose Flower Oil, Thuja Occidentalis Leaf Extract, Ferula Galbaniflua (Galbanum) Resin Oil, Portulaca Oleracea Extract

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  • PURPOSE

    Purpose: UVA / UVB Protection

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  • WARNINGS

    Warnings:
    1. Stop use and ask doctor if any of the following symptoms occur.
    1) Rash, swelling, itchiness, or irritation develops and lasts.
    2) Rash, swelling, itchiness, or irritation on applied areas due to contact with direct sunlight.
    2. Do not apply on wounds, areas inflicted with eczema, or dermatitis.
    3. Guidelines for preservation/handling
    1) Enclose lid/cap after use.
    2) Keep out of reach of infants and young children.
    3) Keep out of direct sunlight, and preserve in room temperature.
    4) Scooping spilled materials back into the container may cause contamination.
    4. Upon first use, make sure to apply a small dab, initially, in order to check for adverse reactions.
    5. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Not to be swallowed if swallowed,
    6. Do not swallow. If swallowed, get medical help or contact a poison control center right away.
    7. Conditions for Preservation: 50-86F.
    8. SPF & UVA level has been indicated strictly by the "International SPF Test Method" and "KFDA (Korea Food and Drug Administration)".
    7. For external use only

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of infants and young children.

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  • INDICATIONS AND USAGE

    Indication and usage:
    Apply generously and evenly before sun exposure. It is effective to use right before going out.

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  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    Take a small amount of Mild Sun Cream SPF25 PA++ about 1.0-1.5g

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  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    GOONG SECRET MILD SUN  SPF25 PA PLUS PLUS
    zinc oxide, titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43319-050
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (ZINC CATION) ZINC CATION 2.82 mg  in 60 mL
    Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide 1.98 mg  in 60 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Ethylhexyl Palmitate  
    Butylene Glycol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43319-050-01 60 mL in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 02/01/2013
    Labeler - 0to7 Inc (557805132)
    Registrant - 0to7 Inc (557805132)
    Establishment
    Name Address ID/FEI Business Operations
    0to7 Inc 557805132 manufacture(43319-050)
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