FDA.reportPublic FDA data

ORLASKIN HYDRATING SUNSCREEN

Product NDC
83447-003
11-digit product format
834470003
Labeler code
83447
Product ID
83447-003_479ede48-5b2e-5407-e063-6394a90aab53
Type
HUMAN OTC DRUG
Nonproprietary name
ORLASKIN HYDRATING SUNSCREEN
Dosage form
SPRAY
Route
CUTANEOUS
Labeler
Guangzhou Fantesy Biotechnology Co.,Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-19
Substance
OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength
8; 10; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL
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
ORLASKIN HYDRATING SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE8 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0808b0cd-2cfb-8554-e063-6294a90ad6c4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83447-003-01ORLASKIN HYDRATING SUNSCREEN100 mL in 1 BOXSPRAY1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83447-003ORLASKIN HYDRATING SUNSCREEN SPRAY [GUANGZHOU FANTESY BIOTECHNOLOGY CO.,LTD]2Current NDC, 1 package rows20240810_0808b0cd-2cfb-8554-e063-6294a90ad6c4.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 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
83447-003-0183447000301100 mL in 1 BOX (83447-003-01) 100 ml2023-10-19NoNoCurrent