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 |
|---|---|---|---|---|---|---|
| City Skin Age Defense Broad Spectrum SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Murad, LLC | f8c572a2-b4bc-49e9-95df-359f05bd69b7 | 2025-03-28 | Warnings | M020 |
| HEB SPF 50 Rejuvenate Sunscreen with Moisturizing Oils and Vitamins Continuous Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | H.E.B | 314c54ed-32f8-5c20-e063-6394a90a0af5 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( blueberry) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 314f8990-4b33-e2b1-e063-6394a90a4d79 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( bubble gum) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31507a62-09a7-6bcc-e063-6394a90aa575 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Birthday cake) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3152bd5d-474f-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Bubble Gum Flavored | LIP BALM SPF15 BUBBLE GUM FLAVORED | LS Promotions Inc | 3152bd5d-4750-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Cocount Pina Colada) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31538f32-9f71-bd40-e063-6394a90a1cd8 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Birthday Cake flavored | LIP BALM SPF15 BIRTHDAY CAKE FLAVORED | LS Promotions Inc | 3153bc6a-8f60-ea37-e063-6294a90acd97 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Apple pie) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3153e1fe-1c43-def0-e063-6294a90a6b3a | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Strawberry Shortcake flavored | LIP BALM SPF15 STRAWBERRY SHORTCAKE FLAVORED | LS Promotions Inc | 315402e4-c1ec-150f-e063-6294a90ae29e | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Vanilla) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3154206c-00b3-e5e3-e063-6394a90afee8 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Passion Fruit) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31544568-c556-72b2-e063-6294a90ace91 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Peppermint) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31548583-ecc7-2e1e-e063-6394a90a2402 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( strawberry) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3154b0f0-2025-4514-e063-6394a90a70c4 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Tropical Punch Flavored | LIP BALM SPF15 TROPICAL PUNCH FLAVORED | LS Promotions Inc | 3154ae45-e075-f53b-e063-6294a90aed5b | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Passion Fruit flavored | LIP BALM SPF15 PASSION FRUIT FLAVORED | LS Promotions Inc | 31552e96-980c-8120-e063-6294a90af3da | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( tropical punch) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 315579e7-e1fb-d6f5-e063-6294a90af06a | 2025-03-27 | Warnings | M020 |
| Shea Moisture | NOURISHED AND RADIANT BROAD SPECTRUM SPF 30 SUNSCREEN FACE LOTION | Conopco d/b/a/ Unilever | 3159be1c-9678-5b1a-e063-6294a90acd08 | 2025-03-27 | Warnings | M020 |
| CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30 | HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE | LOreal USA Products Inc | 7d9e8c07-d295-4c8e-a52f-bdb509dc489b | 2025-03-27 | Warnings | M020 |
| Superactive Moisturizer SPF 50 Mattifying Oil plus Pore Control SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Murad, LLC | 8d89ebf5-bcd5-4fde-a7d4-059023e00f33 | 2025-03-27 | 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 |