Home NDC 83447-003 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 Ingredient Strength OCTOCRYLENE 8 g/100mL HOMOSALATE 10 g/100mL OCTISALATE 5 g/100mL AVOBENZONE 3 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83447-003-01 ORLASKIN HYDRATING SUNSCREEN 100 mL in 1 BOX SPRAY 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83447-003 ORLASKIN HYDRATING SUNSCREEN SPRAY [GUANGZHOU FANTESY BIOTECHNOLOGY CO.,LTD] 2 Current NDC, 1 package rows 20240810_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 178 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunforgettable Total Protection Sport Stick ZINC OXIDE Colorescience d3c0d2b0-f411-565d-e053-2a95a90a081b 2025-10-15 Warnings Exact identifier application number: M020 Defend and Balance TInted Mineral Sunscreen SPF 50 SUNSCREEN Epicuren Discovery 41367f05-59d8-6736-e063-6394a90a5f17 2025-10-15 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE Edgewell Personal Care Brands LLC 41376da3-5274-b133-e063-6394a90afa13 2025-10-15 Warnings Exact identifier application number: M020 Curology Daily Moisturizing Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Curology ee59d52e-5dc6-4fb4-96d8-0bda40e23009 2025-10-15 Warnings Exact identifier application number: M020 SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET ZINC OXIDE Colorescience f4aa14ed-6c6f-8301-e053-2a95a90a5e23 2025-10-15 Warnings Exact identifier application number: M020 Curology The Lip Balm Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Curology Inc. e441b13f-cb58-457f-e053-2a95a90adab9 2025-10-15 Warnings Exact identifier application number: M020 Curology Everyday Sunscreen Broad Spectrum SPF 30 No-clog UV defense ZINC OXIDE Curology 39a2a297-3af2-40d3-8b5d-f4eef2487fb2 2025-10-15 Warnings Exact identifier application number: M020 Colorescience Total Protection No Show Mineral Sunscreen ZINC OXIDE Colorescience 00d8bf32-aecd-22da-e063-6294a90a7567 2025-10-15 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Sand ZINC OXIDE Cosmetic Enterprises Ltd 253c105b-215b-1e6e-e063-6294a90a11d7 2025-10-14 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Tan ZINC OXIDE Cosmetic Enterprises Ltd 265bbb1a-ba96-6598-e063-6394a90a9415 2025-10-14 Warnings Exact identifier application number: M020 Resist Wrinkle Defense SPF 30 Paulas Choice ZINC OXIDE Cosmetic Enterprises Ltd d658fdc7-9dac-47bf-8e83-1433a29a6cf6 2025-10-14 Warnings Exact identifier application number: M020 SPF 50 Face Sunscreen Bioelements AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Cosmetic Enterprises Ltd 498b16c8-ba54-4a0a-8dbc-4b5cc368e214 2025-10-14 Warnings Exact identifier application number: M020 Skin Balancing Ultra Sheer Daily Defence SPF 30 Paulas Choice AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE Cosmetic Enterprises Ltd 3bf31626-5580-457b-8a59-cc37f4ab0767 2025-10-14 Warnings Exact identifier application number: M020 Sunscreen Broad Spectrum SPF 30 Light Tropical Scent ZINC OXIDE Cosmetic Enterprises Ltd d8c7b82d-6151-2199-e053-2a95a90a6c20 2025-10-14 Warnings Exact identifier application number: M020 TOCOBO Cotton Airy Sun Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE PICTON CO., Ltd. 412975d8-0b8b-23bf-e063-6294a90a5568 2025-10-14 Warnings Exact identifier application number: M020 TOCOBO Bio Watery Sun Screen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE PICTON CO., Ltd. 4129e00b-951d-adbf-e063-6294a90a675e 2025-10-14 Warnings Exact identifier application number: M020 Sunny Sailor First Mate Face Stick SPF 30 ZINC OXIDE SUNNY SAILOR LLC c7908385-ff93-4c6c-9462-081c73023571 2025-10-13 Warnings Exact identifier application number: M020 Cloud Brush On Sunscreen SPF 50 ZINC OXIDE FUTURE 8 LLC 8b1eaf6c-9cd8-4c5e-beac-b8539c332ae3 2025-10-13 Warnings Exact identifier application number: M020 Sunplus Mist Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC 951a7bdc-d5c5-4241-a482-c30a4b44f776 2025-10-13 Warnings Exact identifier application number: M020 Sunplus Mist Sunscreen SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC da338ba7-7a92-4157-97f4-5ae9cc64853c 2025-10-13 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83447-003-01 83447000301 100 mL in 1 BOX (83447-003-01) 100 ml 2023-10-19 No No Current