FDA.reportPublic FDA data

ATOBOS CENTELLA BABY SUN

Manufacturer
1004LABORATORY
Effective date
2015-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:26

Label at a glance#

ProductATOBOS CENTELLA BABY SUN
Active ingredientTitanium Dioxide, Zinc oxide
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

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

DESCRIPTION SECTION

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 cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69739-120-012020-01-31C16284748780-19d75b9d0-4d59-f424-e053-dadaa90a57ce1030a55e-8159-4645-bda0-13e1d89f00e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69739-120-01ATOBOS CENTELLA BABY SUN50 mL in 1 CARTONCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69739-120ATOBOS CENTELLA BABY SUN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [1004LABORATORY]1Legacy NDC, 1 package rows20150831_1030a55e-8159-4645-bda0-13e1d89f00e7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc oxideACTIVE INGREDIENTSOI2LOH54Z1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC CATIONACTIVE MOIETY13S1S8SF371
Centella AsiaticaINACTIVE INGREDIENT7M867G6T1U1
Dicaprylyl CarbonateINACTIVE INGREDIENT609A3V1SUA1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69739-12069739-120-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc oxideSOI2LOH54ZACTIM
Centella Asiatica7M867G6T1UIACT
Dicaprylyl Carbonate609A3V1SUAIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f7880bce-ad38-4710-9cbf-336b8c9b2a2d1030a55e-8159-4645-bda0-13e1d89f00e72015-08-31WarningsExact identifier
spl id: f7880bce-ad38-4710-9cbf-336b8c9b2a2d
spl set id: 1030a55e-8159-4645-bda0-13e1d89f00e7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.