FDA.reportPublic FDA data

Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen

Product NDC
85638-008
11-digit product format
856380008
Labeler code
85638
Product ID
85638-008_3caae3b8-9b0d-5c5e-e063-6294a90a5c50
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
GNL BRANDS INTERNATIONAL, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-06
Substance
ZINC OXIDE
Active strength
206 mg/g
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 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE206 mg/g

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
3caaea85-0dfe-6f69-e063-6294a90a7d4aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85638-008-37Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen156 g in 1 CANSPRAY1561

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 40 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45f7953-c103-4900-e053-2a95a90ae3992026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c888ce-3a3f-972b-e053-2a95a90a4fe32026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKNI TINTPML NYC, LLCf4c44eb6-0a3d-2848-e053-2a95a90a58f32026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8925c-ac54-43b1-e053-2995a90a916c2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8b011-5e1d-378c-e053-2a95a90a09cf2026-04-18WarningsExact identifier
application number: M020
EltaMD UV Daily SPF40ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.d967b7d0-453a-4420-886a-70ecf46528d22026-04-17WarningsExact identifier
application number: M020
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
application number: M020
HOLIKA HOLIKA ALOE CICA UV Defense SunscreenAVOBENZONE, HOMOSALATE, OCTISALATEEnprani Co., Ltd.4fa30449-5332-1492-e063-6394a90a585f2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
application number: M020
FORGESKINMINERAL TALLOW SUNSCREENGUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD4fa7e67d-cfc5-9f73-e063-6394a90ada502026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.0e18d601-700a-4c1c-a434-22582253bd952026-04-17WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion BronzeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.ddb3aa5e-cd1a-4792-b1b1-3604b368e0102026-04-17WarningsExact identifier
application number: M020
House of Colour Tinted Sunscreen SPF 50ZINC OXIDEHouse of Colour, Inc.763f5534-cda1-43f2-8a37-1eaa6a43c2e82026-04-17WarningsExact identifier
application number: M020
Sugargirl SPF 30 Sunscreen Illuminating Stick SunlightHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC28c9f019-34fe-4568-ba35-38eb3c4cb19e2026-04-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85638-008-3785638000837156 g in 1 CAN (85638-008-37) 156 g2025-02-06NoNoCurrent