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 |
|---|---|---|---|---|---|---|
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 241 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | a100b05a-06b7-4c65-9822-3f62ca029f40 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 331 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | c3dd293c-8819-4406-af60-41b632a8c00f | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 342 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | 99a92fc5-9a3e-434a-9a5b-3cc47efeea53 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 351 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | e6cd9c7a-29ef-4132-a3e5-575dddb36a9e | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | ea630f2c-49a7-4900-a0ac-b0e1c554aff9 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | cc9c9b69-a0ea-44ac-a590-2cd241ce3162 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | e38a10a8-73ac-4fc5-bbde-537ccb845e6f | 2026-01-22 | Warnings | M020 |
| Designer Lip Smoothie SPF 15 Lip Balm | AVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUM | Australian Gold | 6fd1bd4f-ef94-42b5-a26c-2a02718c113f | 2026-01-22 | Warnings | M020 |
| Australian Gold SPF 15 Lip Balm | OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLY | Australian Gold | 92966c2d-b61a-4f8b-a5c1-8dfb6352c82f | 2026-01-22 | Warnings | M020 |
| LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50g | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE | DONGDONGGURIMOO CO.,LTD. | 4907eb9c-3978-27ed-e063-6394a90a9f66 | 2026-01-22 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | be9f7608-cfaa-4b16-83dd-0580047af56c | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6b27df44-c441-4ae8-a1b0-a9cf2fff6f21 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3c295f6b-6202-a2e1-e063-6394a90a9a60 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | b2eee48f-b644-403c-a57e-04a1491bc386 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | ebcc2c6c-a039-48d5-8c1c-5b347254c4c2 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6967f8bc-3092-44a9-926a-6c11676425e5 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 37d4d8c1-e76b-48a3-9a13-f0543af1b28f | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | fa5046f2-a6db-4ac3-a78f-1b5df075d7e8 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 0c5fc63f-1899-4406-944a-1cdcdf8b4277 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 58a84ecd-3f27-40fc-8e0b-e29192679e6b | 2026-01-21 | 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 |