FDA.reportPublic FDA data

Sunscreen 100

Manufacturer
CMS LAB Inc. | Kolmar Korea Co., Ltd.
Effective date
2017-10-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:52:53

Label at a glance#

ProductSunscreen 100
Active ingredientTITANIUM DIOXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

- Apply the adequate amount onto the entire face at the last stage of your skin care routine. Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips. - Apply liberally 15 minutes before sun exposure. - Reapply at least every 2 hours. - Use a water-resistant sunscreen if swimming or sweating. - Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titamiun Dioxdie (2.52%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

- do not apply on other parts of the body

- do not use on damaged or broken skin

- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

- do not apply directly to wound or open cut

Stop use and ask a doctor if

- Rash or irritation on skin develops and lasts

Directions

DOSAGE & ADMINISTRATION SECTION

- Apply the adequate amount onto the entire face at the last stage of your skin care routine.

Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips.

- Apply liberally 15 minutes before sun exposure.

- Reapply at least every 2 hours.

- Use a water-resistant sunscreen if swimming or sweating.

- Children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, DIBUTYL ADIPATE, POLYGLYCERYL-2 CAPRATE, SUCROSE STEARATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, STEARIC ACID, ALUMINA, GLYCERYL CAPRYLATE, SQUALANE, GLYCERIN, C12-15 ALKYL BENZOATE, PROPANEDIOL, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, PORTULACA OLERACEA EXTRACT, BUTYLOCTYL SALICYLATE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, ARACHIDYL GLUCOSIDE, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL TRIAZONE, CETEARYL ALCOHOL, SACCHARIDE HYDROLYSATE, SALVIA HISPANICA SEED EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, GLYCERYL STEARATE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL, PANTHENOL, SODIUM STEAROYL GLUTAMATE, POLYACRYLATE CROSSPOLYMER-6, t-BUTYL ALCOHOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, XANTHAN GUM, ETHYLHEXYLGLYCERIN, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, PALMITIC ACID, CHOLESTERYL MACADAMIATE, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN

Sunscreen 100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunscreen100sunscreen100

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52554-1111-22020-01-31C16284748780-19d75b9d0-6e8c-f424-e053-dadaa90a57ceSunscreen 100

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52554-1111-1Sunscreen 10050 mL in 1 TUBECREAM503
52554-1111-2Sunscreen 1001 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52554-1111SUNSCREEN 100 (TITANIUM DIOXIDE) CREAM [CMS LAB INC.]3Legacy NDC, 2 package rows20171105_5bec4efd-2511-e6e1-e053-2a91aa0af4df.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52554-111152554-1111-1, 52554-1111-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL724GKU717MIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SQUALANEGW89575KF9IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPANEDIOL5965N8W85TIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
ALUMINUM OXIDELMI26O6933IACT
GLYCERINPDC6A3C0OXIACT
CENTELLA ASIATICA7M867G6T1UIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DOCOSANOL9G1OE216XYIACT
PURSLANEM6S840WXG5IACT
POLYSILICONE-15F8DRP5BB29IACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
ETHYLHEXYL TRIAZONEXQN8R9SAK4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SACCHARIDE HYDROLYSATEED959S6ACYIACT
CHIA SEEDNU0OLX06F8IACT
TURMERIC856YO1Z64FIACT
WATER059QF0KO0RIACT
DIBUTYL ADIPATEF4K100DXP3IACT
SUCROSE STEARATE274KW0O50MIACT

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
5bec4efd-2512-e6e1-e053-2a91aa0af4df5bec4efd-2511-e6e1-e053-2a91aa0af4df2017-10-19WarningsExact identifier
spl id: 5bec4efd-2512-e6e1-e053-2a91aa0af4df
spl set id: 5bec4efd-2511-e6e1-e053-2a91aa0af4df

Reported adverse events (FAERS/openFDA)#

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