FDA.reportPublic FDA data

ORLASKIN HYDRATING SUNSCREEN

Product NDC
83447-003
Requested package NDC
83447-003-01
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 134 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Primer Anti-AgingTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351aaaad-44ce-3558-e063-6294a90a2b462025-12-11Exact identifier
application number: M020
Total Body Block SunscreenZINC OXIDEADR SUNCARE38f4928c-6389-5aa1-e063-6294a90a8f9d2025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f574ad-c4bf-fca1-e063-6394a90a00c52025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f5a0b9-bbe2-50f4-e063-6294a90a10d72025-12-11Exact identifier
application number: M020
Daily Tinted Antioxidant Mineral SunscreenZINC OXIDEMONIKA G KIRIPOLSKY MD INC.3b3f19c1-4bff-315f-e063-6394a90a9a852025-12-11WarningsExact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37dd83db-aa43-7f66-e063-6294a90a893b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37de01d0-7694-69c1-e063-6394a90acf0a2025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37dd5228-5fe4-5e7b-e063-6294a90adffb2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37ddc177-376d-b2fe-e063-6294a90a5e072025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37de2f44-e0da-0d1c-e063-6294a90ae18b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37de5a51-0bc4-34ad-e063-6294a90a0eef2025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d51157-1bcd-79c8-e063-6394a90aba712025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d4b998-c29c-ff89-e063-6394a90a12d82025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEILANI VIDAL36d5831a-7128-729a-e063-6394a90a80362025-12-11Exact identifier
application number: M020
Mineral Matte Non-Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac219bd-dfc8-fe22-e063-6394a90a4a8c2025-12-11WarningsExact identifier
application number: M020
Tinted Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac25d06-d885-48a2-e063-6294a90a0d0b2025-12-11WarningsExact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac27b6c-1341-1f05-e063-6394a90a98602025-12-11WarningsExact identifier
application number: M020
Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37287e4c-6fdf-62c5-e063-6394a90a12962025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37284de3-32d4-3611-e063-6394a90a63932025-12-11Exact identifier
application number: M020
Mineral Lip Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST3728ec6a-7de5-bbc5-e063-6294a90a31b72025-12-11Exact 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