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 |
|---|---|---|---|---|---|---|
| SOME BY MI V10 HYAL AIR FIT SUNSCREEN | SUNSCREENT | PERENNEBELL | fe2148db-9020-9343-e053-6294a90adf70 | 2025-11-13 | Warnings | M020 |
| skin MD | OCTINOXATE, OCTISALATE, HOMOSALATE | 21st Century Formulations | e809e1d3-0a6d-730d-e053-2a95a90aedb9 | 2025-11-13 | Warnings | M020 |
| Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening System | TITANIUM DIOXIDE, ZINC OXIDE | Obagi Cosmeceuticals LLC | a64045dd-8f70-43f1-be6f-ad1556c0e210 | 2025-11-13 | Warnings | M020 |
| Florida Glow SPF 50 | AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATE | Southeast Holdings Corp. | dcb43ee0-5ab0-495a-8e68-90cab881337d | 2025-11-12 | Warnings | M020 |
| Florida Glow SPF 30 | AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATE | Southeast Holdings Corp. | 20538bc0-10c3-492c-952a-6797e46003f2 | 2025-11-12 | Warnings | M020 |
| Florida Glow SPF 15 | AVOBENZONE,OCTOCRYLENE,OCTISALATE | Southeast Holdings Corp. | 56af704a-bda9-49ed-a177-a8480d90458b | 2025-11-12 | Warnings | M020 |
| Florida Glow face shield SPF 55 | HOMOSALATE, OCTOCRYLENE, ZINC OXIDE | Southeast Holdings Corp. | cea54600-5308-4b9f-98ca-fef0b26d79c1 | 2025-11-12 | Warnings | M020 |
| Florida Glow SPF 30 | ZINC OXIDE | Southeast Holdings Corp. | 4bf1ca6b-5d87-40ee-97f4-89f1bfadcecb | 2025-11-12 | Warnings | M020 |
| TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15 | AVOBENZONE,HOMOSALATE,OCTISALATE | Renuskin LLC | e36efd74-11c2-4850-9529-1c88b7364a33 | 2025-11-12 | Warnings | M020 |
| TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80min | AVOBENZONE,HOMOSALATE,OCTISALATE | Renuskin LLC | 22a40d93-ca67-4b7d-a95c-22f52cd6d297 | 2025-11-12 | Warnings | M020 |
| ZEUS | ZINC OXIDE | NEWPORT APOTHECARY, INC | 5354c383-08f0-4b89-b36a-96a35f47be3c | 2025-11-12 | Warnings | M020 |
| Practical Alchemy Hydrating SPF 30 | ZINC OXIDE | Over Here, LLC | 2f07df5b-dbd4-494c-a7cf-55843fb4d7c2 | 2025-11-12 | Warnings | M020 |
| Dr Lift SPF 50 Mineral Sunscreen Stick | ZINC OXIDE | Spa de Soleil | 436fdf4f-11db-7c5b-e063-6294a90a8731 | 2025-11-12 | Warnings | M020 |
| CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | L'Oreal USA Products Inc | 3676aa91-c90d-4a7a-b02e-d5b35304a04d | 2025-11-12 | Warnings | M020 |
| HYDRATING GLOW MIST SPF 50 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | df3bd18d-63b4-460f-bf1c-115ad35edd96 | 2025-11-11 | Warnings | M020 |
| Zinka Clear Zinc Oxide Sunscreen | OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE | Zinka, Inc. | 7b097f5e-8127-49e6-8a77-4ee1fded5ff1 | 2025-11-11 | Warnings | M020 |
| Total Sun Protection | OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE | Cosmed Dermaceuticals, Inc. | dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f | 2025-11-11 | Warnings | M020 |
| Sunsorb Reef Safe SPF15 | HOMOSALATE, OCTOCRYLENE, AVOBENZONE | QS Key West Aloe, LLC | 1a1c17c4-4912-4573-9f59-cbd14a014cb4 | 2025-11-11 | Warnings | M020 |
| Sunsorb Reef Safe SPF30 | HOMOSALATE, OCTOCRYLENE, AVOBENZONE | QS Key West Aloe, LLC | 14f65b3d-90bf-4689-aa6e-879e06153db9 | 2025-11-11 | Warnings | M020 |
| Sunsorb Reef Safe SPF50 | HOMOSALATE, ZINC OXIDE, OCTOCRYLENE | QS Key West Aloe, LLC | b4fc7a51-a163-4057-8790-f2111668ec67 | 2025-11-11 | 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 |