Cream
- Product NDC
- 61354-115
- 11-digit product format
- 613540115
- Labeler code
- 61354
- Product ID
- 61354-115_08a1e862-b55b-fb84-e063-6294a90a016a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Oxygen Development LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-26
- Substance
- ZINC OXIDE
- Active strength
- 21.76 mg/100mg
- 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
- Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 21.76 mg/100mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08a1e862-b55a-fb84-e063-6294a90a016a | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-115-01 | Cream | 100 mg in 1 TUBE | CREAM | 100 | 1 | |
| 61354-115-02 | Cream | 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 |
|---|---|---|---|---|---|---|
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | The Kroger Co. | 22aa46af-5d0f-4256-8f45-be06f6627561 | 2026-08-10 | Warnings | M020 |
| Colorescience Total Protection No Show Mineral Body Shield | ZINC OXIDE | Colorescience | 52e1f59e-63cb-7480-e063-6394a90ad7c5 | 2026-08-10 | Warnings | M020 |
| Eucerin Radiant Tone Tinted Sunscreen SPF 50 | AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 596a4204-3d29-9023-e063-6294a90ad99e | 2026-08-10 | Warnings | M020 |
| Journee Firm Riche Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | Merz North America, Inc. | d4d4bfcf-3674-4847-8ad8-1716a8e821ae | 2026-08-10 | Warnings | M020 |
| ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen | BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE | Grace and Fire USA Inc. | 56ad0dce-410e-9d78-e063-6294a90a1c3e | 2026-08-09 | Warnings | M020 |
| ORLASKIN SPF50 Antioxidant SoothingComplex Sunscreen | ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE | Guangzhou Yapheon Health Industry Co., Ltd. | 552a36ed-7a66-4048-e063-6394a90a09bc | 2026-08-08 | Warnings | M020 |
| lip balm SPF15( 2533) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 5870aa44-1375-cdc5-e063-6394a90af4a5 | 2026-08-07 | Warnings | M020 |
| lip balm SPF15( Zinc oxide) 01 | ZINC OXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 5871ab1d-cf07-d737-e063-6394a90a58fe | 2026-08-07 | Warnings | M020 |
| VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen | TITANIUM DIOXIDE, OCTINOXATE | LCM TECHNOLOGY Co., Ltd | 4cbbf8aa-8910-b7e7-e063-6294a90a4f07 | 2026-08-07 | Warnings | M020 |
| AVOBENZONE, HOMOSALATE, OCTISALATE | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 58636012-7e29-7206-e063-6394a90a83e9 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| AVOBENZONE, HOMOSALATE, OCTISALATE | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5864275d-a480-06f8-e063-6394a90aecab | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5864881c-c495-1f32-e063-6294a90a1304 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Elta MD UV Daily Peptide Lip Balm SPF 40 | ZINC OXIDE | CP Skin Health Group, Inc | 945538b5-5745-42cf-b610-0018ca2ec254 | 2026-08-06 | Warnings | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 58653d79-8fff-f319-e063-6294a90af7a3 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5865f0e5-14b2-c4bf-e063-6294a90a4710 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Stream2Sea Ecostock SPF 40 Sunscreen | ZINC OXIDE | Stream2Sea, LLC | 5866e026-a652-3300-e063-6394a90acff0 | 2026-08-06 | Warnings | M020 |
| NHLMA Skin Defense Sunscreen | BROAD SPECTRUM SPF 30 | NATIONAL HAIR LOSS LLC | 56326ae0-387f-ad08-e063-6294a90acc4f | 2026-08-06 | Warnings | M020 |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 37fee381-ce6b-4949-9a4a-778aa839fb84 | 2026-08-06 | Warnings | M020 |
| Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Kenvue Brands LLC | 129ae274-0094-be5e-e063-6394a90a9801 | 2026-08-05 | Warnings | M020 |
| Leader Kids Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH 110, LLC. DBA LEADER | 3636693a-ba81-5d49-e063-6394a90a3006 | 2026-08-05 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61354-115-01 | 61354011501 | 100 mg in 1 TUBE | 100 mg | Historical | |||
| 61354-115-02 | 61354011502 | 1 TUBE in 1 CARTON (61354-115-02) / 100 mg in 1 TUBE (61354-115-01) | 1 tube | 2023-10-26 | No | No | Current |