FDA.reportPublic FDA data

ATOMY MINERAL COMPACT NO.13

Manufacturer
ATOMY CO., LTD. | Kolmar Korea Co.,Ltd. Bucheon Factory
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:06:52

Label at a glance#

ProductATOMY MINERAL COMPACT NO.13
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 18.310%, ZINC OXIDE 1.920%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

MICA,TALC,SILICA,DIMETHICONE,BORON NITRIDE,DIISOSTEARYL MALATE,TRIFLUOROMETHYL C1-4 ALKYL DIMETHICONE,TRIETHOXYCAPRYLYLSILANE,DIPHENYLSILOXY PHENYL TRIMETHICONE, NYLON-12,POLYMETHYL METHACRYLATE,TRIETHYLHEXANOIN,IRON OXIDES(CI 77492), DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE,
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,GLYCERYL CAPRYLATE,POLYGLYCERYL-2 TETRAISOSTEARATE,SILICA DIMETHYL SILYLATE,METHICONE,IRON OXIDES(CI 77491),CAPRYLYL GLYCOL,ALUMINUM MYRISTATE,ALUMINUM HYDROXIDE,DISODIUM STEAROYL GLUTAMATE, TRIMETHYLSILOXYSILICATE,ALUMINUM DIMYRISTATE,FRAGRANCE(PARFUM),MYRISTIC ACID, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE,TOCOPHERYL ACETATE,IRON OXIDES(CI 77499),ALUMINA,AQUA/WATER/EAU,CALCIUM CARBONATE,HYDROXYAPATITE,ZEA MAYS (CORN) STARCH,PISTACIA LENTISCUS (MASTIC) GUM,PROPOLIS WAX,ROYAL JELLY EXTRACT,ACETYL HEXAPEPTIDE-8

PURPOSE

OTC - PURPOSE SECTION

Sunscreen agent

WARNINGS

WARNINGS SECTION

For extral 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 exporsure by limiting time in the sun, wearing protective clothing, and using a sunscreen.
When using this product, keep out of eyes. Rinse water to remove.
Stop use and ask a doctor, if rash or irritation develops and lasts.

Do not use
• Areas of eczema, skin inflammation, or after injury

When using this produt
• Discontinue use if irritation or rash appear.
• Keep out of eyes
• Rinse with water to remove

Ask a doctor before use if you have
• Poor blood circulation
• Irritated skin
• Any area that is infected or reddened
• Diabetes

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

DESCRIPTION

DESCRIPTION SECTION

Uses:

• Provides moderate protection against adverse effects of the sun.
• Higher SPF gives more sunburn protection.
• Helps prevent sunburn.
• Effective for the skin highly sensitive to sunburn.


Directions
• Apply liberally before sun exporsure.
• Children under 6 months of age: ask a doctor.
• Reapply as needed or after towel drying, swimming or perspiring.
• Not intended for protection while sunbathing.

Other information

OTHER SAFETY INFORMATION

• Store at 20-25 degrees C (68-77 degrees F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC CATIONACTIVE MOIETY13S1S8SF371
MICAINACTIVE INGREDIENTV8A1AW08801
TALCINACTIVE INGREDIENT7SEV7J4R1U1

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
52257-127052257-1270-1

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
MICAV8A1AW0880IACT
TALC7SEV7J4R1UIACT

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 · 35 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 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
bf60af5e-cd4e-41ee-9beb-405e0f123b4758499640-45fd-48fb-b47b-9b1636fb9f0c2021-10-29WarningsExact identifier
spl set id: 58499640-45fd-48fb-b47b-9b1636fb9f0c

Reported adverse events (FAERS/openFDA)#

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