OS-01 Lip SPF BS SPF15
- Product NDC
- 84451-004
- 11-digit product format
- 844510004
- Labeler code
- 84451
- Product ID
- 84451-004_351d69f9-5ae2-1dec-e063-6294a90ad7a1
- 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
- 2025-05-07
- Substance
- ZINC OXIDE
- Active strength
- 5.5 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 Lip SPF BS SPF15
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 5.5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 351d55f6-fcd9-1d47-e063-6294a90a2cf0 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84451-004-01 | OS-01 Lip SPF BS SPF15 | 12 g in 1 TUBE | CREAM | 12 | 1 | |
| 84451-004-02 | OS-01 Lip SPF BS SPF15 | 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 |
|---|---|---|---|---|---|---|
| Bath and Body Works SPF Coconut | AVOBENZONE,HOMOSALATE,OCTISALATE | Bath & Body Works, Inc. | 56078491-f7d6-97f7-e063-6394a90a6deb | 2026-07-07 | Warnings | M020 |
| Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxide | ZINC OXIDE | Surprise Enterprise LLC | 38cf4325-9720-f511-e063-6394a90ad628 | 2026-07-07 | Warnings | M020 |
| Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 560c0f35-2132-52a6-e063-6394a90a2d24 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Bonnie | CIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIE | Delicate Cosmetics Inc | 560d1d19-87a6-179b-e063-6294a90ada5e | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Kelly | CIELE LIP AND PROTECT LIPSTICK SPF 60 KELLY | Delicate Cosmetics Inc | 560df34a-e6da-0792-e063-6394a90a7e71 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 LouLou | CIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOU | Delicate Cosmetics Inc | 560e37ae-87c0-39d2-e063-6394a90a2af4 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Cassette | CIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTE | Delicate Cosmetics Inc | 560e4198-b07c-3d48-e063-6394a90a7be3 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Margaux | CIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUX | Delicate Cosmetics Inc | 560e47d5-c881-438c-e063-6394a90a3091 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Saddle | CIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLE | Delicate Cosmetics Inc | 560e5de5-1350-4046-e063-6394a90abffa | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Puzzle | CIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLE | Delicate Cosmetics Inc | 560e5558-8e46-7736-e063-6294a90acb05 | 2026-07-07 | Warnings | M020 |
| EELHOE Body Coverage Perfector | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 5610c3b7-456b-3bc1-e063-6394a90a3fa8 | 2026-07-07 | Warnings | M020 |
| Sunscreen SPF 50 | AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% | Worthy Promotional Products | 1d4be26a-4695-491c-85d1-86824e1cd029 | 2026-07-06 | Warnings | M020 |
| SPF 30 Sunscreen | HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3% | Coconut Caliente Costa Rica LLC | 71856cb3-9386-4569-80e4-92826342e386 | 2026-07-06 | Warnings | M020 |
| Stay Ageless Sunscreen | BROAD SPECTRUM SPF 30 | TOXFAIRY, LLC | 55f7e07e-1689-6d38-e063-6294a90a9119 | 2026-07-06 | Warnings | M020 |
| Premier Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Emerald Aesthetics LLC | 55f88dd1-346c-22a5-e063-6294a90a711f | 2026-07-06 | Warnings | M020 |
| RR Sun | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Undefined Inc | 87244432-2967-4145-89cd-11a7567083a3 | 2026-07-06 | Warnings | M020 |
| TOCOBO Cotton Airy Sun Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON CO., Ltd. | 35af90d3-dfe1-30dc-e063-6294a90a10a5 | 2026-07-05 | Warnings | M020 |
| MDP PEPTIDE 9 BIO SUN PRO | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | SKINIDEA CO., LTD | 26db53cd-dd82-8790-e063-6394a90a92b1 | 2026-07-03 | Warnings | M020 |
| SPF 50 plus Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Theravita LLC | d8e276cc-0292-499d-9075-a83a2d3fafcc | 2026-07-02 | Warnings | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | The Kroger Co. | 5880b275-91fc-4589-a076-0e55409425d8 | 2026-07-02 | Warnings, Adverse reactions | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84451-004-01 | 84451000401 | 12 g in 1 TUBE | 12 g | Historical | |||
| 84451-004-02 | 84451000402 | 1 TUBE in 1 CARTON (84451-004-02) / 12 g in 1 TUBE (84451-004-01) | 1 tube | 2025-05-07 | No | No | Current |