FDA.reportPublic FDA data

Dr.G BRIGHT TONING UP TINTED SUNSCREEN

Product NDC
51621-021
11-digit product format
516210021
Labeler code
51621
Product ID
51621-021_52dca633-73c4-3bd8-e063-6394a90abfc2
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTISALATE, HOMOSALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
GOWOONSESANG COSMETICS CO., LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
Substance
OCTISALATE; HOMOSALATE; ZINC OXIDE
Active strength
3.5; 3.5; 19.2 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dr.G BRIGHT TONING UP TINTED SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE3.5 g/100mL
HOMOSALATE3.5 g/100mL
ZINC OXIDE19.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30d34459-b7fb-b0c6-e063-6294a90a08acAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51621-021-01Dr.G BRIGHT TONING UP TINTED SUNSCREEN50 mL in 1 CONTAINERCREAM502
51621-021-01Dr.G BRIGHT TONING UP TINTED SUNSCREEN1 in 1 BOXCREAM12

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 248 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINTZINC OXIDEBentley Laboratories, LLC6edd51e5-1c42-4e66-b5ca-abfea2dad8f82024-12-27WarningsExact identifier
application number: M020
Tone Control Morning Cream SPF 15OCTOCRYLENE AND OCTISALATE CREAMBentley Laboratories, LLCb4e3cd1c-ae42-4995-a314-96d24d328e412024-12-27WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)ZINC OXIDEZO Skin Health, Inc.be25489e-c3bf-77c5-e053-2a95a90a30de2024-12-27WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Tropical Coconut SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC55ad5d2f-a855-491e-a287-13689f8abff12024-12-27WarningsExact identifier
application number: M020
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
application number: M020
Powerbright Moisturizer SPF 50OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATEDermalogica, LLC.02c731ee-c5cb-4158-9b1f-e826593c35262024-12-27WarningsExact identifier
application number: M020
INVISIBLE PHYSICAL DEFENSE SPF30ZINC OXIDEDermalogica, Inc.2e5e6861-25ea-4605-8e59-41d852c002b72024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLCdec3b0d1-f06e-4acf-8ba2-64167e774abc2024-12-27WarningsExact identifier
application number: M020
Clearing Defense SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDermalogica, Inc.2388ae53-0a61-43c0-8936-c639887a56492024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e3-e4fc-e063-6394a90a491d2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d832-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Morphe SPF 30 Broad Spectrum Sunsetter SettingOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d34406f-9dd0-3909-e063-6394a90ab9f92024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c64cc0-be42-c210-e063-6394a90a6d9a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edda-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d839-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d83b-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c618ae-3d24-8c87-e063-6394a90a53962024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d830-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDECOSMAX USA, CORPORATION0d35fa3c-e6eb-d9ff-e063-6394a90a5a6e2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c6035e-c178-b3e6-e063-6394a90a86cd2024-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51621-021-01516210021011 CONTAINER in 1 BOX (51621-021-01) / 50 mL in 1 CONTAINER1 container2025-08-01NoNoCurrent