FDA.reportPublic FDA data

ATOMY SUNSCREEN

Manufacturer
ATOMY CO., LTD. | Kolmar Korea Co.,LTD. Gwanjeong Factory
Effective date
2019-12-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:49:13

Label at a glance#

ProductATOMY SUNSCREEN BEIGE BROAD SPECTRUM SPF50 PLUS
Active ingredientOctinoxate, Octisalate, Zinc Oxide, Titanium Dioxide
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Octinoxate 6.8%, Octisalate 4.5%, Zinc Oxide 13.44%, Titanium Dioxide 4.88%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

AQUA/WATER/EAU , CYCLOPENTASILOXANE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, DICAPRYLYL CARBONATE, BUTYLOCTYL SALICYLATE, PEG-10 DIMETHICONE, DISTEARDIMONIUM HECTORITE, PORTULACA OLERACEA EXTRACT, MAGNESIUM SULFATE, DIMETHICONE, ALUMINUM HYDROXIDE, MICA, PHENOXYETHANOL, ALUMINUM STEARATE, FRAGRANCE(PARFUM), TRIETHOXYCAPRYLYLSILANE, METHICONE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, IRON OXIDES(CI77492), STEARIC ACID, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, IRON OXIDES(CI77491), AMINOPROPYL DIMETHICONE, POLYMETHYLSILSESQUIOXANE, IRON OXIDES(CI77499), CAMELLIA SINENSIS LEAF EXTRACT, THYMUS VULGARIS (THYME) OIL, ALTHAEA OFFICINALIS LEAF/ROOT EXTRACT, MELISSA OFFICINALIS EXTRACT, BORAGO OFFICINALIS EXTRACT, CENTELLA ASIATICA EXTRACT, JASMINUM OFFICINALE (JASMINE) EXTRACT, PERILLA OCYMOIDES LEAF EXTRACT

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings:

For external use only. UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor, if rash or irritation develops and lasts.

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION

DESCRIPTION SECTION

Uses: Helps prevent sunburn. Effective for sensitive skin easily prone to sun burns.

Directions: Apply liberally before sun exposure. Children under 6 months of age: ask a doctor Reapply as needed or after swimming, perspiring, or towel drying.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.atomy.com/sunscreen atomy carton.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD512
OctisalateACTIVE INGREDIENT4X49Y0596W2
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP2
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
ZINC CATIONACTIVE MOIETY13S1S8SF372
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C402
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52257-123052257-1230-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
Zinc OxideSOI2LOH54ZACTIM
Titanium Dioxide15FIX9V2JPACTIB
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
b5482383-870a-4295-b486-9ed60026d6260bdd67d5-201a-4863-84f3-3477707785b72021-10-29WarningsExact identifier
spl set id: 0bdd67d5-201a-4863-84f3-3477707785b7

Reported adverse events (FAERS/openFDA)#

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