FDA.reportPublic FDA data

Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen

Product NDC
85638-004
11-digit product format
856380004
Labeler code
85638
Product ID
85638-004_3c6e7e6c-6bba-d88f-e063-6394a90afb5f
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
GNL BRANDS INTERNATIONAL, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-14
Substance
ZINC OXIDE
Active strength
206 mg/mL
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
Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE206 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
3c6e7e62-4313-cbce-e063-6394a90ac382Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85638-004-66Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen100 mL in 1 TUBELOTION1001

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 136 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
application number: M020
Soft Focus Mineral Defense TintedTITANIUM DIOXIDE, ZINC OXIDESPOTLESS SKIN STUDIO387f1ea9-4764-3abe-e063-6394a90adde02025-12-11Exact identifier
application number: M020
flawless photo finishZINC OXIDENEXTEX CORPORATION35bb0ac4-6abd-ca75-e063-6394a90a26cd2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352efbee-cab4-c515-e063-6294a90a46f22025-12-11Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e6e79-94db-dbb1-e063-6394a90aefd62025-12-11Exact identifier
application number: M020
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
application number: M020
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incroporated352fe5e4-8b3f-248f-e063-6394a90ab42c2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incorporated3530898c-7bdf-6ffe-e063-6394a90aa0372025-12-11Exact identifier
application number: M020
Equate SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart Inc45b4d41b-c9ac-2c26-e063-6294a90a614f2025-12-11WarningsExact identifier
application number: M020
Mint ConditionZINC OXIDEMint Skin Incorporated353031d7-cc2d-426c-e063-6394a90a99ea2025-12-11Exact identifier
application number: M020
Body ProtectZINC OXIDENoble Center for Healthy Aging LLC387df843-b7d3-df2e-e063-6294a90a93f22025-12-11Exact identifier
application number: M020
Everyday Mineral Tinted SunscreenZINC OXIDEAtlanta Acne Specialists, LLC351e6ca8-c6cb-dd99-e063-6294a90af0cf2025-12-11Exact identifier
application number: M020
Mint ConditionZINC OXIDEMint Skin Incorporated3530efd2-b122-9aba-e063-6394a90a89532025-12-11Exact identifier
application number: M020
The Tinted Mineral SunscreenZINC OXIDEThe Hue Solution L.L.C.37f30a04-8ffa-09de-e063-6294a90aba052025-12-11Exact identifier
application number: M020
Abib Airy clear sunscreen gel Smoothing tubeHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEFourcompany Co., Ltd.33d1a5da-68c3-b16e-e063-6294a90a70062025-12-10WarningsExact identifier
application number: M020
Non Tinted Mineral Moisturizing SunscreenZINC OXIDEABOUT FACE AESTHETICS, INC.3647a985-5365-a9e0-e063-6294a90ac0a42025-12-10Exact identifier
application number: M020
ProtectME Tinted Mineral SPF 40 20%ZINC OXIDEPUREFECTION LA, INC.33dd1afa-25a8-891f-e063-6294a90a8c8a2025-12-10Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85638-004-6685638000466100 mL in 1 TUBE (85638-004-66) 100 ml2025-02-14NoNoCurrent