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 |
|---|---|---|---|---|---|---|
| Pelotan Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Pelotan LLC | 3a9f94eb-98b7-5a20-e063-6394a90a173b | 2025-07-23 | Warnings | M020 |
| Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a9fc050-f74f-a431-e063-6294a90ad4c2 | 2025-07-23 | Warnings | M020 |
| Pelotan Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Pelotan LLC | 3aa0799b-0790-2476-e063-6294a90a8bcc | 2025-07-23 | Warnings | M020 |
| The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN | ZINC OXIDE | Guangzhou Haishi Biological Technology Co., Ltd. | 3aa3c442-26a6-0ab0-e063-6294a90a93a5 | 2025-07-23 | Warnings | M020 |
| Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a89106d-dbf0-e6ea-e063-6294a90a60f3 | 2025-07-22 | Warnings | M020 |
| Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a898964-b4aa-e86d-e063-6394a90a34c6 | 2025-07-22 | Warnings | M020 |
| No7 Future Renew Damage Reversal System Kit | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | BCM Cosmetique SAS | 3512c120-b8ba-ba59-e063-6394a90ac1e2 | 2025-07-22 | Warnings | M020 |
| Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a89d736-efef-088e-e063-6394a90a5e62 | 2025-07-22 | Warnings | M020 |
| Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8a093b-cc9c-26fc-e063-6394a90a2028 | 2025-07-22 | Warnings | M020 |
| Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8a87d6-ef86-60c2-e063-6394a90a0706 | 2025-07-22 | Warnings | M020 |
| Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8b773c-f456-836a-e063-6294a90a0d46 | 2025-07-22 | Warnings | M020 |
| Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8bc90d-350f-98c8-e063-6294a90abd9c | 2025-07-22 | Warnings | M020 |
| Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8bd5d8-1c4c-0407-e063-6394a90a138f | 2025-07-22 | Warnings | M020 |
| CLEAR GLOW RADIANT SUN SERUM SPF50 | AVOBENZONE 15MG/G, HOMOSALATE 5MG/G, OCTOCRYLENE 25MG/G, (SUNSCREEN) | NAKED SUNDAYS PTY LTD | d748e291-3a29-663c-e053-2995a90a8d92 | 2025-07-22 | Warnings | M020 |
| La Defense Broad Spectrum SPF 30 Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | Luzern Laboratories, Inc | 3f00befa-415d-415d-89e1-6ba8770ba51e | 2025-07-21 | Warnings | M020 |
| PREDIRE PARIS skin shield protector mineral defense cream | PREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAM | Guangzhou Fantesy Biotechnology Co.,Ltd | 3a7c1345-532f-b38f-e063-6394a90a5245 | 2025-07-21 | Warnings | M020 |
| Medicated Peppermint Lip Balm | DIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATE | Blistex Inc | 5d48a6fa-ddce-47c3-9b09-1f3abb695017 | 2025-07-18 | Warnings | M020 |
| ICD Moisture Layer Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | ICD Moisture Layer Sunscreen | 3a2a74f2-9fed-808f-e063-6294a90a410c | 2025-07-18 | Warnings | M020 |
| Counter Beauty Dew Skin Tinted Moisturizer No. 2 | ZINC OXIDE | G2G Ventures, PBC | 3a35c95b-10eb-689f-e063-6394a90ae1d4 | 2025-07-18 | Warnings | M020 |
| Counter Beauty Dew Skin Tinted Moisturizer No. 3 | ZINC OXIDE | G2G Ventures, PBC | 3a35bbb2-a1eb-346b-e063-6294a90a9078 | 2025-07-18 | 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 |