Your browser does not support JavaScript! GOONG SECRET MILD SUN SPF25 PA PLUS PLUS (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [0TO7 INC]
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GOONG SECRET MILD SUN SPF25 PA PLUS PLUS (zinc oxide, titanium dioxide) cream
[0to7 Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

ACTIVE INGREDIENT

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

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

PURPOSE

Purpose: UVA / UVB Protection

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of infants and young children.

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

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GOONG SECRET MILD SUN  SPF25 PA PLUS PLUS
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43319-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (ZINC CATION) ZINC CATION2.82 mg  in 60 mL
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide1.98 mg  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Ethylhexyl Palmitate 
Butylene Glycol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43319-050-0160 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2013
Labeler - 0to7 Inc (557805132)
Registrant - 0to7 Inc (557805132)
Establishment
NameAddressID/FEIBusiness Operations
0to7 Inc557805132manufacture(43319-050)

Revised: 4/2013
 
0to7 Inc

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