FDA.reportPublic FDA data

Ocean Potion Suncare 30 Continuous Sunscreen Scent of Sunshine

Product NDC
85638-003
11-digit product format
856380003
Labeler code
85638
Product ID
85638-003_3e60bd4f-c7d9-1c8b-e063-6394a90aeef8
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
GNL BRANDS INTERNATIONAL, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-30
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 100; 20; 50 mg/g; mg/g; mg/g; 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 30 Continuous Sunscreen Scent of Sunshine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE100 mg/g
OCTOCRYLENE20 mg/g
OCTISALATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e60bd44-1984-57c6-e063-6294a90a1f4eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85638-003-37Ocean Potion Suncare 30 Continuous Sunscreen Scent of Sunshine156 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 235 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Meet Your Flawless Matte Skin DuoOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDESocoplan3541c41b-f114-4734-a66f-be309ca6f3bf2025-01-16WarningsExact identifier
application number: M020
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
application number: M020
Snap On Racing Sunscreen KitAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGreater Pacific Industries, Inc.9f4f91d0-0fc5-43a3-be79-afce5afa2f952025-01-16WarningsExact identifier
application number: M020
Emme Diane Pure Protection Tinted Antioxidant SunscreenZINC OXIDEEmme Diane, Inc.b2b4daf5-765b-426d-8a72-9278f7cd43d72025-01-16WarningsExact identifier
application number: M020
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
application number: M020
Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40ZINC OXIDESUNNY SAILOR LLC14ea2d11-c425-45d8-a23a-d4ed82a6439c2025-01-15WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30GLO SKIN BEAUTY OIL-FREE TINTED PRIMER SPF 30Hayden Caleel LLC00bf7331-c9dc-4a8a-9ff3-901e0d07eac62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc42f6f-4eaf-fa28-e063-6294a90a93fb2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEBlack Girl Sunscreen, LLC2bc419b3-4de2-7ed9-e063-6394a90a255f2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc47bd0-d81b-f1b9-e063-6394a90ad3752025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50OCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONEBlack Girl Sunscreen, LLC2bc46854-fe67-782b-e063-6294a90a79af2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATEBlack Girl Sunscreen, LLC2bc471f0-c93e-0c51-e063-6394a90a77f02025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4b1b1-5f19-7ba3-e063-6394a90a5de72025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4c639-787a-d2d3-e063-6394a90a5ded2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4d937-77d0-273c-e063-6394a90a25e72025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4cfd9-e44c-9b93-e063-6394a90a96a62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4e22d-6265-9c0b-e063-6394a90a15412025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4eb32-8c0b-32fc-e063-6294a90a16252025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc50182-30f2-b77e-e063-6394a90a63552025-01-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85638-003-3785638000337156 g in 1 CAN (85638-003-37) 156 g2024-08-30NoNoCurrent