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 |
|---|---|---|---|---|---|---|
| Centellian24 Madeca Derma Shield Vital Airy Sun Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | 70541 | 44e11009-ffcb-dd59-e063-6294a90add22 | 2026-01-27 | Warnings | M020 |
| Sunscreen SPF50 | NON NANO ZINC OXIDE | SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI | c5d52f13-a649-9579-e053-2a95a90a062c | 2026-01-27 | Warnings | M020 |
| ONSART Mineral Sunscreen SPF 50 | ZINC OXIDE 24% | Guangzhou Huixue Biotechnology Co., Ltd. | 495e3266-a59f-42f7-e063-6394a90adfa3 | 2026-01-27 | Warnings | M020 |
| Poolside Sun Daze Body Illuminator SPF 30 Shimmer Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 54868d6f-ae4c-476d-8c77-c4a72b13d2ea | 2026-01-27 | Warnings | M020 |
| Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the Face | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | dd036e0c-0c27-42b3-9d2c-33839a8631f9 | 2026-01-27 | Warnings | M020 |
| Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink Ice | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | ea23616f-1d59-4e32-88bb-d035af727728 | 2026-01-27 | Warnings | M020 |
| Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic Twist | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 21b6239b-26d0-4b6b-8aee-fe1f20d8aaea | 2026-01-27 | Warnings | M020 |
| Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla Icing | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 483b6873-fe58-4a38-bf82-df116617c5f0 | 2026-01-27 | Warnings | M020 |
| Zinc Oxide 20% | SUNSCREEN SPF 50 MINERAL | S&C Hampton Sun | 4960930e-a1bf-d850-e063-6294a90a4084 | 2026-01-27 | Warnings | M020 |
| Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi | CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFI | LE COSMETICS INC | 4963658b-59bb-b313-e063-6394a90a0a51 | 2026-01-27 | Warnings | M020 |
| Golden Glow SHIMMER MIST | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | 4963e513-d1fc-4b0e-e063-6394a90a7ddf | 2026-01-27 | Warnings | M020 |
| Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Rio | CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIO | LE COSMETICS INC | 49644002-153f-c254-e063-6394a90a46eb | 2026-01-27 | Warnings | M020 |
| Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo | CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABO | LE COSMETICS INC | 49643a56-3627-67f8-e063-6294a90a2d7b | 2026-01-27 | Warnings | M020 |
| Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Caymans | CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANS | LE COSMETICS INC | 49644002-153e-c254-e063-6394a90a46eb | 2026-01-27 | Warnings | M020 |
| Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | 496ba4c4-6577-88ff-e063-6294a90a0995 | 2026-01-27 | Warnings | M020 |
| Vacation Lip Balm | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation INC. | b442530f-cae3-418b-9675-c18879653826 | 2026-01-27 | Warnings | M020 |
| EltaMD UV Clear Blemish-Prone and Oil Balancing | OCTINOXATE AND ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 6337b9e3-2524-4292-8fc8-1f6aad6cfe05 | 2026-01-27 | Warnings | M020 |
| SPF Ginger Sunscreen SPF 50 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | SPF GINGER LLC | f303ad78-5fa3-40d1-9b1c-53ae1ca73aed | 2026-01-26 | Warnings | M020 |
| ALOE UP COCO-MANGO SPF-50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Aloe Care International, LLC | 8506049f-cb43-4d1d-885b-c6d3a99bbba3 | 2026-01-26 | Warnings | M020 |
| ALOE UP COCO-MANGO SPF-50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Aloe Care International, LLC | 144178e7-2df9-49c3-9667-43986cee89c4 | 2026-01-26 | 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 |