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 |
|---|---|---|---|---|---|---|
| Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | 03b0f2ee-526b-4513-b70a-2918ad322b5e | 2025-11-19 | Warnings | M020 |
| Invisible Sunscreen SPF 40 | HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE | PARTICLE AESTHETIC SCIENCE LTD | 1b33b4fb-1deb-69f7-e063-6294a90a9cc0 | 2025-11-19 | Warnings | M020 |
| Softlips Vanilla | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 8dff782f-7201-4ad9-94d2-672058f817b8 | 2025-11-19 | Warnings | M020 |
| Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30 | AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONE | Baxter Laboratories Pty. Ltd. | 43923c68-87ad-1ab7-e063-6394a90adf7a | 2025-11-18 | Warnings | M020 |
| Illuminizing Blendrops Broad Spectrum SPF 46 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 43e36351-4caf-3393-e063-6394a90a00b1 | 2025-11-18 | Warnings | M020 |
| Perfecting Blendrops Broad Spectrum SPF 46 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 43e454cf-dac8-4c2f-e063-6394a90a7097 | 2025-11-18 | Warnings | M020 |
| Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 Sunscreen | HOMOSALATE, OCTOCRYLENE, ZINC OXIDE | H.E.B. | 43e55eb7-6572-bd88-e063-6294a90aa7ee | 2025-11-18 | Warnings | M020 |
| ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Merle Norman Cosmetics, Inc. | d10272ea-aedd-5759-e053-2a95a90a3ab3 | 2025-11-18 | Warnings | M020 |
| DAYDREAM Broad Spectrum Sunscreen SPF 40 | ZINC OXIDE | Drmtlgy, LLC | bd0981cb-49ce-4eaf-bd9e-db48f56b7314 | 2025-11-18 | Warnings | M020 |
| SPF 25 LIP BALM | AVOBENZONE, OCTISALATE, HOMOSALATE | Drmtlgy, LLC | 8aed2fb0-f7b8-4ff0-b597-144c0557789e | 2025-11-18 | Warnings | M020 |
| Sunny Defense Sunscreen Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | RBGROUP Co., Ltd | 262450f0-c4a1-dcca-e063-6394a90ae3cd | 2025-11-17 | Warnings | M020 |
| Tone Blur Essence Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | RBGROUP Co., Ltd | 1814b5e7-5bbf-df16-e063-6294a90a96c4 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c48c66-bd5b-0024-e063-6394a90a6c7b | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c512da-e4b6-dd9c-e063-6294a90a1730 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c52258-2549-c42b-e063-6394a90a1526 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c59de6-8eb2-d00a-e063-6294a90a0b04 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5bd02-62e0-019a-e063-6294a90adcf3 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5d54e-119c-0c6d-e063-6394a90aba4c | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5eb1c-b268-acfb-e063-6394a90ad4cc | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c6157a-4b62-8279-e063-6294a90abe05 | 2025-11-17 | 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 |