GOONGSECRET BABY SUN SPF35 PA PLUS PLUS PLUS

Dosage form: lotion
Ingredients: ZINC OXIDE 9.216g in 80g, TITANIUM DIOXIDE 5.632g in 80g
Labeler: 0to7 Inc
NDC Code: 43319-010

Disclaimer: 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 Facts

Active ingredients: ZINC OXIDE 11.52%, TITANIUM DIOXIDE 7.04%

Inactive ingredients:
Water, Viscum Album (Mistletoe) Fruit Extract, Vigna Radiata Seed Extract, Thuja Occidentalis Leaf Extract, Stearic Acid, Squalane, Sophora Japonica Root Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Salix Alba (Willow) Bark Extract, Rose Flower Oil, Prunus Persica (Peach) Leaf Extract, Prunus Mume Flower Extract, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Polyhydroxystearic Acid,Polydecene, Phellodendron Amurense Bark Extract, Pelargonium Graveolens Flower Oil, PEG-10 Dimethicone, Olea Europaea (Olive) Fruit Oil, Oenothera Biennis (Evening Primrose) Oil, Morus Alba Stem Extract,Morus Alba Bark Extract, Mangifera Indica (Mango) Seed Butter, Lithospermum Erythrorhizon Root Extract, Lavandula Angustifolia (Lavender) Oil, Jasminum Officinale (Jasmine) Oil, Illicium Verum (Anise) Fruit/Seed Oil, Hydrogenated Rapeseed Oil, Houttuynia Cordata Extract, Helianthus Annuus (Sunflower) Seed Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Glyceryl Caprylate, Glycerin, Ferula Galbaniflua (Galbanum) Resin Oil, Disodium EDTA, Dipotassium Glycyrrhizate, Dimethicone/Methicone Copolymer, Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Copaifera Officinalis (Balsam Copaiba) Resin, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Chrysanthemum Morifolium Flower Extract, Cetyl PEG/PPG-10/1 Dimethicone, Centella Asiatica Leaf Extract, Cedrus Atlantica Bark Oil, Caprylyl Glycol, Caprylic/Capric Triglyceride, Camellia Japonica Flower Extract, Butylene Glycol, Borago Officinalis Seed Oil, Beeswax, Artemisia Princeps Leaf Extract, Artemisia Absinthium Extract, Angelica Acutiloba Root Extract, Aluminum Hydroxide, Alcohol Denat

Purpose: UVA/UVB Protection

Warnings:
1. Before the first using, make sure if there is any skin irratants or not by using this  product on your skin a bit.
2. Do not use on wounds, eczema, dermatitis, mucous membrane in oral.
3. Do not get into eyes. If contact occurs, clean the eyes with water immediately.
4. Stop using when this product irritates your skin, or if
   1) skin rash, swelling, and itchiness occurs
   2) same symptoms of the above occurs with direct sunlight after using this product. if condition worsens, seek medical help or consult with dermatologist.
5. Caution for treatment and keeping.
   1) Tighten the lid after using.
   2) Do not keep the product in direct sunlight or at an extremely high or low temperature.
   3) Once dispensed from a container, do not put the content in the container again. It may cause spoilage.
6. SPF and ultraviolet A blocking grade of this product has been tested in accordance with methods and measurement of Korea Food and Drug Administration.
7. For external use only, not to be swallowed

Keep out of reach of children:
In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Indication and usage:
Apply generously and evenly before sun exposure and as needed.

Dosage and administration: 1.0-1.5g

GOONGSECRET BABY SUN  SPF35 PA PLUS PLUS PLUS
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43319-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC OXIDE9.216 g  in 80 g
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE5.632 g  in 80 g
Inactive Ingredients
Ingredient NameStrength
WATER 
VISCUM ALBUM FRUIT 
STEARIC ACID 
SQUALANE 
STYPHNOLOBIUM JAPONICUM ROOT 
SALIX ALBA BARK 
PRUNUS PERSICA LEAF 
PRUNUS MUME FLOWER 
PONCIRUS TRIFOLIATA FRUIT 
PHELLODENDRON AMURENSE BARK 
PELARGONIUM GRAVEOLENS FLOWER OIL 
OLIVE OIL 
EVENING PRIMROSE OIL 
MORUS ALBA STEM 
MORUS ALBA BARK 
MANGIFERA INDICA SEED BUTTER 
LITHOSPERMUM ERYTHRORHIZON ROOT 
LAVENDER OIL 
JASMINUM OFFICINALE FLOWER 
GLYCYRRHIZA GLABRA 
GLYCERYL CAPRYLATE 
GLYCERIN 
GALBANUM OIL 
EDETATE DISODIUM 
DIMETHICONE 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
Packaging
#Item CodePackage Description
1NDC:43319-010-0180 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2012
Labeler - 0to7 Inc (557805132)
Registrant - 0to7 Inc (557805132)
Establishment
NameAddressID/FEIOperations
0to7 Inc557805132manufacture

Revised: 06/2012
 
0to7 Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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