FDA.reportPublic FDA data

Sky and Sol Sunscreen SPF30

Product NDC
83447-007
11-digit product format
834470007
Labeler code
83447
Product ID
83447-007_479eea4a-9a7e-6776-e063-6394a90a4557
Type
HUMAN OTC DRUG
Nonproprietary name
Sky and Sol Sunscreen SPF30
Dosage form
CREAM
Route
TOPICAL
Labeler
Guangzhou Fantesy Biotechnology Co.,Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-19
Substance
ZINC OXIDE
Active strength
15 g/100g
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
Sky and Sol Sunscreen SPF30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15 g/100g

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
1d917329-dea2-e792-e063-6294a90a0a0dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83447-007-01Sky and Sol Sunscreen SPF3085 g in 1 BOXCREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83447-007SKY AND SOL SUNSCREEN SPF30 CREAM [GUANGZHOU FANTESY BIOTECHNOLOGY CO.,LTD]2Current NDC, 1 package rows20240810_1d917329-dea2-e792-e063-6294a90a0a0d.zip

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 173 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Land Shark SPF 8OCTINOXATE AND OXYBENZONETropical Seas, Inc.b5e68448-4131-1c6c-e053-2a95a90a014a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 40ZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d204c38c-b5d1-3511-e053-2a95a90a9dc82025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e4e63c-3e51-0a78-e053-2a95a90abd872025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.8cd68b09-2578-4519-b00e-e83e0e4408152025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e44be7-3a46-34e2-e053-2a95a90a96602025-11-04WarningsExact identifier
application number: M020
Reef Kids SPF 30 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.005a9e7c-e392-4b9a-911f-d7586f7ae94e2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559d349-2ffd-492c-e053-2995a90aab062025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pink BeachZINC OXIDETropical Seas, Inc.d240e6c9-d053-9924-e053-2a95a90a855a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 15OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e49c6f-477b-aafc-e053-2a95a90a982a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559e03b-f5d3-bd72-e053-2995a90a31ca2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Clear ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d128269b-73fa-e5f3-e053-2995a90af1ed2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50 SportOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e40a7c-b49d-cfc3-e053-2995a90ac27e2025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.d5ed3488-aa32-4a63-9996-12c6532c3a4d2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559499c-6109-bf5e-e053-2995a90a4ac72025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e24ca1-d041-355d-e053-2995a90a3d612025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5570cbd-89f5-65d5-e053-2995a90a54d12025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Azure BlueZINC OXIDETropical Seas, Inc.d23fe61a-3ffb-59d0-e053-2995a90a59e62025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b55a0bd0-2a32-2977-e053-2a95a90aa1422025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.06d43525-86d8-f2d9-e063-6394a90afc812025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pacific PurpleZINC OXIDETropical Seas, Inc.d240fe7c-9d16-78c9-e053-2a95a90a763c2025-11-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83447-007-018344700070185 g in 1 BOX (83447-007-01) 85 g2024-07-19NoNoCurrent