ATOBOS BABY SUN- titanium dioxide, zinc oxide cream 
1004LABORATORY

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.

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ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 11.25%, Zinc oxide 4.75%

INACTIVE INGREDIENT

Inactive Ingredients: Centella Asiatica Extract, 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

Purpose: Sunscreen

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

Indications & Usage: After washing the face & body, dispense an appropriate amount into your palm, and evenly apply to the entire face and body.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ATOBOS BABY SUN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69739-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide5.62 mg  in 50 mL
Zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.37 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
Witch Hazel (UNII: 101I4J0U34)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69739-060-0150 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2015
Labeler - 1004LABORATORY (689512629)
Registrant - 1004LABORATORY (689512629)
Establishment
NameAddressID/FEIBusiness Operations
1004LABORATORY689512629manufacture(69739-060)

Revised: 7/2015
Document Id: b2851401-f27b-4251-822d-07aa318061f8
Set id: d3d0d005-4215-4133-ad8a-13833b86777a
Version: 1
Effective Time: 20150724
 
1004LABORATORY