FDA.reportPublic FDA data

Mineral Sunscreen Broad Spectrum SPF30

Manufacturer
COSMECCA KOREA CO., LTD
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:43

Label at a glance#

ProductMineral Sunscreen Broad Spectrum SPF30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Immediately after towel drying  At least every 2 hours Children under 6 months of age: Ask a doctor  Sun Protection Measures. Spending time in the sun increases your risk of a skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 3.44%

ZINC OXIDE 4.88%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

when using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor 

OTC - STOP USE SECTION

If swallowed. get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Immediately after towel drying 
  • At least every 2 hours
  • Children under 6 months of age: Ask a doctor 
  • Sun Protection Measures. Spending time in the sun increases your risk of a skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.-2 p.m.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PROPANEDIOL, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLOCTYL SALICYLATE, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, NIACINAMDE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, OLIVE OIL POLYGLYCERYL-6 ESTERS, POLYSILICONE-11, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-6 PENAOLEATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, STEARIC ACID, ALPHA-GLUCAN OLIGOSACCHARIDE, SILICA, VITIS VINIFERA (GRAPE) SEED OIL, BISABOLOL, CAFFEINE, TRIETHOXYCAPRYLYLSILANE, ALUMINA, POLYMNIA SONCHIFOLIA ROOT JUICE, POLYHYDROXYSTEARIC ACID, MALTODEXTRIN, SODIUM HYALURONATE, PHENOXYETHANOL, LACTOBACILLUS, MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner PackageLabelLabel

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
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53727-121-01Mineral Sunscreen Broad Spectrum SPF3050 g in 1 TUBELOTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53727-121MINERAL SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [COSMECCA KOREA CO., LTD]41 package rows20231216_f65441f7-d9a1-2129-e053-2995a90a3f9b.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53727-12153727-121-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOMENOL24WE03BX2TIACT
CAFFEINE3G6A5W338EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM OXIDELMI26O6933IACT
SMALLANTHUS SONCHIFOLIUS ROOT JUICEM9S7HX36CTIACT
MALTODEXTRIN7CVR7L4A2DIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ARGAN OIL4V59G5UW9XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CHLORIDE451W47IQ8XIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
NIACINAMIDE25X51I8RD4IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HEXYL LAURATE4CG9F9W01QIACT
OLIVE OIL POLYGLYCERYL-6 ESTERS4KDO9AFM9IIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
AVOCADO OIL6VNO72PFC1IACT
POLYGLYCERYL-10 PENTAOLEATEBH1TF96DJCIACT
SHEA BUTTERK49155WL9YIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GRAPE SEED OIL930MLC8XGGIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
0c5bffd9-f247-8bee-e063-6294a90ac249f65441f7-d9a1-2129-e053-2995a90a3f9b2023-12-12WarningsExact identifier
spl id: 0c5bffd9-f247-8bee-e063-6294a90ac249
spl set id: f65441f7-d9a1-2129-e053-2995a90a3f9b

Reported adverse events (FAERS/openFDA)#

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