OS-01 Face SPF BS SPF30 Untinted
- Product NDC
- 84451-003
- 11-digit product format
- 844510003
- Labeler code
- 84451
- Product ID
- 84451-003_22060b23-45e8-c29d-e063-6294a90a4be6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- ONESKIN INC.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-15
- Substance
- ZINC OXIDE
- Active strength
- 17.5 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- OS-01 Face SPF BS SPF30 Untinted
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 17.5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2205ec0e-ac3f-299f-e063-6294a90a2174 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84451-003-01 | OS-01 Face SPF BS SPF30 Untinted | 40 g in 1 TUBE | CREAM | 40 | 1 | |
| 84451-003-02 | OS-01 Face SPF BS SPF30 Untinted | 1 in 1 CARTON | CREAM | 1 | 1 |
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 |
|---|---|---|---|---|---|---|
| Cicatricure Gold Lift SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Genomma Lab USA | 34cc5b3c-af36-e202-e063-6294a90a13a7 | 2025-05-10 | Warnings | M020 |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | The Maui Medical Group, Inc | 34b6aa46-657b-2676-e063-6294a90abadd | 2025-05-09 | M020 | |
| Tinted Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Scottsdale Skin Boutique and Dermatology Pllc | 34a5a99f-9e22-52ab-e063-6294a90a9323 | 2025-05-08 | M020 | |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b7eeeb-09ae-ffe6-e063-6294a90aba90 | 2025-05-07 | Warnings | M020 |
| cle de peau BEAUTE UV PROTECTIVE N | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | fe19a057-a3c6-4c53-92f9-a4a960cd5b08 | 2025-05-07 | Warnings | M020 |
| Winter Survival Kit | OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | Duke Cannon Supply Co. | 2487ab56-7856-66b0-e063-6394a90a9d87 | 2025-05-07 | Warnings | M020 |
| OS-01 Lip SPF BS SPF15 | ZINC OXIDE | Allure Labs | 3490ed60-60b9-dfcd-e063-6394a90ab17a | 2025-05-07 | Warnings | M020 |
| Lip Love Moisture Balm SPF30 - Nude Beige | ZINC OXIDE | Koco Life LLC | 3491084b-348a-f2bf-e063-6394a90abd25 | 2025-05-07 | Warnings | M020 |
| Lip Love Moisture Balm SPF30 - Watermelon | ZINC OXIDE | Koco Life LLC | 3491fb2a-d55f-1736-e063-6294a90a594a | 2025-05-07 | Warnings | M020 |
| Abib Heartleaf mild sunscreen Relief tube | ZINC OXIDE | FOURCOMPANY CO., LTD. | 34965587-c9b7-4066-e063-6394a90ab424 | 2025-05-07 | Warnings | M020 |
| CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Laboratoires Clarins | 157cb8ca-1a36-41fb-be9e-b157b146dc4d | 2025-05-06 | Warnings | M020 |
| Mango Bay SPF 50 Sport | AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE | Inspec Solutions | e25e4f76-8311-491b-e053-2a95a90a4fc8 | 2025-05-06 | Warnings | M020 |
| Mango Bay SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Inspec Solutions LLC. | e260b901-5918-48df-e053-2a95a90a68c3 | 2025-05-06 | Warnings | M020 |
| Mango Bay SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Inspec Solutions LLC. | e25cf8e4-93cd-f5f6-e053-2995a90a4545 | 2025-05-06 | Warnings | M020 |
| Mango Bay SPF 30 Gallon | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Inspec Solutions LLC. | e260c1bc-8b79-abc7-e053-2a95a90ae4d2 | 2025-05-06 | Warnings | M020 |
| Lip Love Moisture Balm SPF30 - Pink Strawberry | ZINC OXIDE | Koco Life LLC | 347e665f-cb59-ab04-e063-6394a90ad0a6 | 2025-05-06 | Warnings | M020 |
| Saucd Toasted Golden Tanning SPF 15 Caramel | AVOBENZONE, OCTISALATE, HOMOSALATE | SAUCD GENERAL TRADING COMPANY | e10d41cd-e03e-401c-9024-263350b3ec2a | 2025-05-05 | Warnings | M020 |
| Visor Clear Body Mist Hydrating Sunscreen SPF 50 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | VISOR SKINCARE LLC | b2d7639c-cbfb-4127-8ee4-7355e0d021e1 | 2025-05-05 | Warnings | M020 |
| Jacket Ultimate Performance Sunscreen SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | BALSHI MD DERMACEUTICALS | d4d82c41-01da-40af-a22c-d4d57af7a2f2 | 2025-05-05 | Warnings | M020 |
| All Good Mineral Sport Sunscreen Butter Stick SPF 50 | ZINC OXIDE | Elemental Herbs, Inc. | 114c6ac8-b133-cd16-e063-6294a90ac4f9 | 2025-05-05 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84451-003-01 | 84451000301 | 40 g in 1 TUBE | 40 g | Historical | |||
| 84451-003-02 | 84451000302 | 1 TUBE in 1 CARTON (84451-003-02) / 40 g in 1 TUBE (84451-003-01) | 1 tube | 2023-08-15 | No | No | Current |