Label: ATOBOS CENTELLA BABY SUN- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69739-120-01 - Packager: 1004LABORATORY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated August 31, 2015
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Centella Asiatica Extract(24%), Dicaprylyl Carbonate, Hamamelis Virginiana (Witch Hazel) Water, Coco-Caprylate/Caprate, Polyglyceryl-3 Diisostearate, Stearic acid, Polyglyceryl-2 Dipolyhydroxystearate, Aluminum hydroxide, Glycerin, Glyceryl Caprylate, Centella Asiatica Leaf Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Galactomyces Ferment Filtrate, Bifida Ferment Lysate, Sodium Chloride, 1,2-Hexanediol, Helianthus Annuus (Sunflower) Seed Oil, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Persea Gratissima (Avocado) Oil, Usnea Barbata (Lichen) Extract, Isoamyl Laurate, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Silica, Sorbitan Olivate, Lactobacillus/Portulaca Oleracea Ferment Extract, Lactobacillus/Punica Granatum Fruit Ferment Extract, Lactobacillus/Pumpkin Ferment Extract, Bacillus/Soybean Ferment Extract, Aspergillus/Saccharomyces/ Barley Seed Ferment Extract, Saccharomyces/Grape Ferment Extract, Hippophae Rhamnoides Seed Oil, Rosa Canina Fruit Extract, Voacanga Africana Seed Extract, Aspergillus/Rice Ferment Extract, Ethyl Ferulate, Cocos Nucifera (Coconut) Oil, Citrus Aurantium Dulcis (Orange) Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil
- PURPOSE
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WARNINGS
Warnings: 1. Stop using the product if the following problems arise while using the product as continued use could worsen the symptoms; consult with a dermatologist. A. If red spots, swelling, itchiness, and irritation occur. B. If the above problems occur on the applied area on the skin from direct sunlight 2. Do not use on areas with wounds, eczema, and dermatitis. 3. Storage and handling precautions. A. Close the lid after use. B. Do not store in high- temperature or low- temperature and keep away from direct sunlight.
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ATOBOS CENTELLA BABY SUN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69739-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 5.62 mg in 50 mL Zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.37 mg in 50 mL Inactive Ingredients Ingredient Name Strength Centella Asiatica (UNII: 7M867G6T1U) Dicaprylyl Carbonate (UNII: 609A3V1SUA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69739-120-01 50 mL in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2015 Labeler - 1004LABORATORY (689512629) Registrant - 1004LABORATORY (689512629) Establishment Name Address ID/FEI Business Operations 1004LABORATORY 689512629 manufacture(69739-120)
