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 212 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TALLOW SUNSCREENNON-NANO ZINC OXIDEFOUNDATION COMMERCE INC363e38bf-b4b4-dcc4-e063-6294a90a5d2f2025-05-28WarningsExact identifier
application number: M020
CoreTex SunX 50 FacestickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc364989ea-c93b-d404-e063-6294a90abd092025-05-28WarningsExact identifier
application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30OCTINOXATE, ZINC OXIDESOLVADERM LLC86dbd8c3-e95a-49a8-afe6-ff9d985e28ba2025-05-27WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350b4cce-1627-5b8f-e063-6294a90aa6bf2025-05-26WarningsExact identifier
application number: M020
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEONESKIN INC.35d57d3f-376c-2307-e063-6294a90adf512025-05-23WarningsExact identifier
application number: M020
Oathology Inzincable Lip Balm SPF 35ZINC OXIDESKINOATH LLC289a5492-af57-42e5-82af-3f1e4b369d682025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, LightZINC OXIDEALLI LLC3cb4459b-1776-414a-b5c4-0ffb9f1df7662025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, DarkZINC OXIDEALLI LLC81633684-f9ac-45cb-8a3e-f0c30b229a822025-05-22WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230NOCTINOXATE, ZINC OXIDEBEL STAR S.A.35c106b6-9a80-01e3-e063-6294a90abc352025-05-22WarningsExact identifier
application number: M020
COSRXAIRY-LIGHT CLEAR SUNCREEN STICKCOSRX inc.313b1a73-8863-c458-e063-6394a90a01d62025-05-20WarningsExact identifier
application number: M020
Melan Antioxidant Body Mist Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMELAN INC.f627b17f-d2dc-47bd-b865-08995995e8612025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.63e078a3-d5df-4458-a745-e306d734e6be2025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.90531e8f-15c6-49ac-96a4-3bdfab2bfd9b2025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB SUNSCREENS AND CLEANSERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.28db9f44-780f-4cd5-940e-3ee779f382472025-05-20WarningsExact identifier
application number: M020
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
application number: M020
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
application number: M020
Coola Clear California SummersOCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATECOOLA, LLC358009c4-492d-ac03-e063-6294a90af2272025-05-19WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEONESKIN INC.3581f578-e19e-9ace-e063-6294a90acc342025-05-19WarningsExact 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