OS-01 FACE SPF BS SPF 30 TINTED DEEP
- Product NDC
- 84451-005
- 11-digit product format
- 844510005
- Labeler code
- 84451
- Product ID
- 84451-005_3581efdc-41fa-a450-e063-6294a90a4e56
- 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
- 2025-05-12
- 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 SPF 30 TINTED DEEP
- 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 |
|---|---|
| 3581f578-e19e-9ace-e063-6294a90acc34 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84451-005-01 | OS-01 FACE SPF BS SPF 30 TINTED DEEP | 40 g in 1 TUBE | CREAM | 40 | 1 | |
| 84451-005-02 | OS-01 FACE SPF BS SPF 30 TINTED DEEP | 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 |
|---|---|---|---|---|---|---|
| Ceile tint PROTECT tinted serum SPF 50 Ivory | CEILE TINT PROTECT TINTED SERUM SPF 50 IVORY | LE COSMETICS INC | 58547809-3480-1032-e063-6294a90a04c6 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Deep | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEP | LE COSMETICS INC | 58549160-3594-9056-e063-6394a90abf7d | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Deep | CEILE TINT PROTECT TINTED SERUM SPF 50 DEEP | LE COSMETICS INC | 585498d4-b29c-9580-e063-6394a90adf1e | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Fair | CEILE TINT PROTECT TINTED SERUM SPF 50 FAIR | LE COSMETICS INC | 58545633-cb36-6611-e063-6394a90a1f07 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Light | CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT | LE COSMETICS INC | 5853ae6b-0eaf-e614-e063-6394a90ae91a | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Light Medium | CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUM | LE COSMETICS INC | 585473c3-3ee9-7d84-e063-6394a90abd33 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM | LE COSMETICS INC | 58547b48-251a-10eb-e063-6294a90ac95c | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Tan | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TAN | LE COSMETICS INC | 58547e38-ae84-82ee-e063-6394a90a27d6 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Tan | CEILE TINT PROTECT TINTED SERUM SPF 50 TAN | LE COSMETICS INC | 58548331-38cd-8668-e063-6394a90a3362 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Honey | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEY | LE COSMETICS INC | 5854861a-376d-8825-e063-6394a90a8aab | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Honey | CEILE TINT PROTECT TINTED SERUM SPF 50 HONEY | LE COSMETICS INC | 585488c5-fac5-212f-e063-6294a90a00ff | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Rich | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICH | LE COSMETICS INC | 585488af-d14f-8d71-e063-6394a90ac4f0 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Rich | CEILE TINT PROTECT TINTED SERUM SPF 50 RICH | LE COSMETICS INC | 58548e6d-9c82-249c-e063-6294a90a11ad | 2026-08-05 | Warnings | M020 |
| 12 Days of Derm-Loved Skincare | OCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE | Rodan & Fields | a13f0275-5add-4464-88d4-ff9823274325 | 2026-08-03 | Warnings | M020 |
| Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY | OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% | Lale Cosmetics LLC | 581fb0cd-c55d-d562-e063-6394a90a7f11 | 2026-08-03 | Warnings | M020 |
| Manyo Air Light Moisturizing Sunscreen SPF 50 | ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Manyo Factory Corp. | 86761577-a32c-41a2-a2e3-b339b1493701 | 2026-08-03 | Warnings | M020 |
| EltaMD UV Active | ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN | CP Skin Health Group, Inc | 39d16479-d491-4c19-aa11-674461687c7b | 2026-08-03 | Warnings | M020 |
| AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30 | OCTISALATE, OCTOCRYLENE, AVOBENZONE | AMBI Enterprises LLC | 99bbe9a2-bb57-4a33-b339-1649d4b319c8 | 2026-07-31 | Warnings | M020 |
| AMBI Even and Clear Facial Moisturizer SPF-30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | AMBI Enterprises LLC | 4701c0ba-4ceb-4d66-9f99-515ce33b4648 | 2026-07-31 | Warnings | M020 |
| Continuous Correction Cream | TITANIUM DIOXIDE | Baxter of California, LLC | 1cbcc648-f2e1-af60-e063-6294a90ad4bb | 2026-07-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84451-005-01 | 84451000501 | 40 g in 1 TUBE | 40 g | Historical | |||
| 84451-005-02 | 84451000502 | 1 TUBE in 1 CARTON (84451-005-02) / 40 g in 1 TUBE (84451-005-01) | 1 tube | 2025-05-12 | No | No | Current |