DOMINAS DARK SPOT TINTED SUNSCREEN

Manufacturer
LG H&H CO., LTD. | fmg Co.Ltd
Effective date
2025-03-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:46

Label at a glance#

ProductDOMINAS DARK SPOT TINTED SUNSCREEN
Active ingredientOCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE
Label structure9 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

For sunscreen use: apply liberally 15 minutes before sun exposure children under 6 months of age: ask a doctor reapply at least every 2 hours use a water resistant sunscree nif swimming or sweating Sun Protection Measures: Spending time in the sun increases your risk of 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 p...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 2.5%

Octocrylene 4%

Titanium Dioxide 1.53%

Zinc Oxide 8.73%

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

Warning

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

When Using

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • reapply at least every 2 hours
  • use a water resistant sunscree nif swimming or sweating
  • Sun Protection Measures: Spending time in the sun increases your risk of 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.-2p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses

Other Information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun
  • the product may stain certain types of fabrics

Questions?

OTC - QUESTIONS SECTION

1-866-993-4709

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, DICAPRYLYL CARBONATE, HEXYL LAURATE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, GLYCERIN, CYCLOPENTASILOXANE, ISOHEXADECANE, DISTEARDIMONIUM HECTORITE, PANTHENOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERYL CAPRYLATE, MAGNESIUM SULFATE, PEG-30 DIPOLYHYDROXYSTEARATE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM STEARATE, ALUMINA, MICA, ETHYLHEXYLGLYCERIN, STEARYL GLYCYRRHETINATE, IRON OXIDES(CI 77492), MYRISTICA FRAGRANS (NUTMEG) EXTRACT, IRON OXIDES(CI 77491), IRON OXIDES(CI 77499), MORINGA OLEIFERA SEED OIL, DIPHENYLSILOXY PHENYL TRIMETHICONE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHRYSIN, 1,2-HEXANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT, HYDROXYCITRONELLAL, LIMONENE, LINALOOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CC

BOTTLEBOTTLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-302-01DOMINAS DARK SPOT TINTED SUNSCREEN50 g in 1 TUBECREAM502
53208-302-02DOMINAS DARK SPOT TINTED SUNSCREEN1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-302DOMINAS DARK SPOT TINTED SUNSCREEN (OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LG H&H CO., LTD.]2Current NDC, 2 package rows20250327_2b6140cf-7e34-1658-e063-6394a90a3271.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53208-30253208-302-01, 53208-302-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

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
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
ndc (package): 53208-302-02
ndc (package): 53208-302-01
ndc (product): 53208-302
ndc11 (package): 53208030202
ndc11 (package): 53208030201
spl id: 311ce9f8-a489-590a-e063-6294a90a52b8
spl set id: 2b6140cf-7e34-1658-e063-6394a90a3271

Reported adverse events (FAERS/openFDA)#

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