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 |
|---|---|
| OCTOCRYLENE | 8 g/100mL |
| HOMOSALATE | 10 g/100mL |
| OCTISALATE | 5 g/100mL |
| AVOBENZONE | 3 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5A68WGF6WM | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0808b0cd-2cfb-8554-e063-6294a90ad6c4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Glow Go Lip Oil | AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, | NAKED SUNDAY PTY LTD | e5aab267-b33b-a40d-e053-2a95a90a9d79 | 2025-04-01 | Warnings | M020 |
| Glow Go Lip Oil | AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, | NAKED SUNDAY PTY LTD | e5beb9cd-aa3b-2b37-e053-2995a90a8409 | 2025-04-01 | Warnings | M020 |
| Glow Go Lip Oil | AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, | NAKED SUNDAY PTY LTD | e5bdc0c8-af2c-1096-e053-2995a90a8917 | 2025-04-01 | Warnings | M020 |
| Mesoestetic Mesoprotech Melan 130 Pigment Control | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | MESOESTETIC PHARMA GROUP SL | 3b50e874-9665-4df4-8b3a-fc932c29f3f6 | 2025-04-01 | Warnings | M020 |
| AVON BEYOND GLOW SUN MOISTURIZER | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG HOUSEHOLD & HEALTH CARE LTD. | 30c83f4f-9de0-6fbf-e063-6394a90af1ae | 2025-04-01 | Warnings | M020 |
| EltaMD UV Daily | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 6dde7055-5f77-4a7f-a182-c03e1f30bfaa | 2025-03-31 | Warnings | M020 |
| natural lip balm SPF15( chocolate sundae) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 319e8e26-b29d-4627-e063-6294a90acfba | 2025-03-31 | Warnings | M020 |
| Face Shield Cream SPF 30 | OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE | Vege Labs | 31aad575-a5d1-42b0-e063-6294a90a6c81 | 2025-03-31 | Warnings | M020 |
| SOLMED SUNSCREEN FACE SHIELD | AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE | FEELFREE LLC | 31b077cc-32b9-78e6-e063-6394a90a155a | 2025-03-31 | Warnings | M020 |
| TATCHA THE SILK SUNSCREEN | ZINC OXIDE | TATCHA INC. | 7799042a-d2de-480e-a8a3-827b3dc27907 | 2025-03-31 | Warnings | M020 |
| Cotz Sensitive SPF 40 Sunscreen | ZINC OXIDE | Fallien Cosmeceuticals, LTD. | 885a674b-3457-4dfe-a801-529094b00499 | 2025-03-31 | Warnings | M020 |
| EltaMD UV Daily Tinted | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | ad8aafdf-f3bc-497f-9792-20c2911c12d0 | 2025-03-31 | Warnings | M020 |
| EltaMD UV Clear Tinted SPF46 | ZINC OXIDE AND OCTINOXATE SUNSCREEN | CP Skin Health Group, Inc. | 1ac59ef1-113e-4ad1-90c3-38353bc7e1ec | 2025-03-31 | Warnings | M020 |
| lip balm SPF15( CB222) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316416d0-52b5-6f2f-e063-6294a90a9bc1 | 2025-03-28 | Warnings | M020 |
| lip balm SPF15( CB400) 01 | OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316463e0-dc1f-e2ae-e063-6394a90a0c3c | 2025-03-28 | Warnings | M020 |
| Sunscreen Stick SPF30( CB400) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316498d9-32fe-f884-e063-6394a90a4307 | 2025-03-28 | Warnings | M020 |
| ALEX MD PHD Sheer Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | PHYSICIAN LABORATORIES INC | 8f64c4fa-92ee-4af0-ab1b-6c3673f9a622 | 2025-03-28 | Warnings | M020 |
| ALEX MD PHD Tinted Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | PHYSICIAN LABORATORIES INC | 93873c34-5c72-43c8-b6c2-c65b596191d7 | 2025-03-28 | Warnings | M020 |
| TRADER JOES SHIMMER GLOW SUNSCREEN SPF 40 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Trader Joe's Company | 316c7793-5937-9ce4-e063-6294a90ae0a1 | 2025-03-28 | Warnings | M020 |
| CeraVe AM Facial Moisturizing Broad Spectrum SPF 50 Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE | L'Oreal USA Products Inc | dc85cff3-df18-4bb7-8d71-bb0878959fe2 | 2025-03-28 | Warnings | M020 |
Packages#
| 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 |