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 306 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clove Hill acne safe mineral sunscreen SPF 40ZINC OXIDEClove Hill LLCa06e6393-13c5-48b9-909a-3bdf7d58cad32024-01-22WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEA-S Medication Solutionsbfb1fdbe-883f-4d1d-9131-a46da98277882024-01-18WarningsExact identifier
application number: M020
LA Bodies Eclipse Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONESAMSON PHARMACEUTICALce3a5ddc-9d4d-4d63-879c-fc4aef9a0a0a2024-01-18WarningsExact identifier
application number: M020
Shunly Zn20 Light MoisturizerZINC OXIDEShunly Skin Care LLCd5710d48-0a4b-49a6-b6b5-9a192afccd2a2024-01-17WarningsExact identifier
application number: M020
Shunly Zn20 Tinted Light MoisturizerZINC OXIDEShunly Skin Care LLCc046eef3-c2d7-42e6-a5ad-98e513fdb4e12024-01-17WarningsExact identifier
application number: M020
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
application number: M020
LA Bodies Eclipse Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONESAMSON PHARMACEUTICAL48708273-764d-4139-ae06-7cf1a273759c2024-01-17WarningsExact identifier
application number: M020
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
application number: M020
NYX Professional Makeup Bare with Me Daily Moisturizing Primer with Cannabis Sativa Seed Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc7f960d4c-ad09-4dc8-b272-66e4df26ace82024-01-16WarningsExact identifier
application number: M020
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
application number: M020
Lancome Paris Bienfait UV 50 Plus Broad Spectrum SPF 50 Plus Water Resistant 80 Minutes Super Fluid Facial SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc6296fbce-93fe-483e-bd60-6ae228afcaad2024-01-15WarningsExact identifier
application number: M020
LOreal Paris AntiSagging Plus Even Tone Collagen Expert Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incdb483af0-797b-4ef5-b02a-ab9fa1ba87fe2024-01-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incbc72048a-4786-44c2-97ce-0220822816542024-01-15WarningsExact identifier
application number: M020
Caring mill Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFSA Store Inc.0ec201dc-c262-cecd-e063-6394a90a3fd32024-01-12WarningsExact identifier
application number: M020
Caring mill Kids Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE,FSA Store Inc.0ec21837-d4f1-0916-e063-6294a90a21992024-01-12WarningsExact identifier
application number: M020
CERAMIDE LIFT and FIRM EYE SPF 15OXYBENZONE, OCTINOXATEREVLONb22f0c13-0a9c-7d38-e053-2a95a90a0ecd2024-01-12WarningsExact identifier
application number: M020
Elizabeth Arden, Great 8, Moisturizer SPF 35AVOBENZONE, OCTISALATE, HOMOSALATERevlonb1b89565-7292-45eb-e053-2a95a90ae8d02024-01-12WarningsExact identifier
application number: M020
CERAMIDE LIFT and FIRMOCTINOXATE, OXYBENZONE, AVOBENZONE, OCTISALATE, OCTOCRYLENEREVLONb20ae6e9-de6e-0059-e053-2a95a90a57602024-01-12WarningsExact 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