Tinted Mineral Sunscreen
- Product NDC
- 85366-204
- 11-digit product format
- 853660204
- Labeler code
- 85366
- Product ID
- 85366-204_4614bcf0-8d3d-d59f-e063-6294a90ad265
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Gentlehomme LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-02
- Substance
- ZINC OXIDE
- Active strength
- 200 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Tinted Mineral Sunscreen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 200 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 365e7d8e-e3e0-4c08-e063-6294a90af415 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85366-204-60 | Tinted Mineral Sunscreen | 60 g in 1 BOTTLE, PUMP | CREAM | 60 | 2 |
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 |
|---|---|---|---|---|---|---|
| SPF 50 Sunscreen Unfragranced | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | 05e4706b-1955-aba8-e063-6294a90a29c7 | 2024-12-19 | Warnings | M020 |
| Rubber Ducky SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | cf32b3a0-de88-b866-e053-2a95a90a3f32 | 2024-12-19 | Warnings | M020 |
| SPF 50 Sunscreen Rocky Mountain | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Derma Care Research Labs, LLC | a216d48f-4ed4-6008-e053-2a95a90a8c9a | 2024-12-19 | Warnings | M020 |
| Rod and Rifle SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Derma Care Research Labs, LLC | fc61847b-cb61-97b1-e053-6394a90ae1b9 | 2024-12-19 | Warnings | M020 |
| Habana Brisa SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | Derma Care Research Labs, LLC | db0d6dec-d0ee-6160-e053-2a95a90a2c6e | 2024-12-19 | Warnings | M020 |
| Caribbean Breeze SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% | Derma Care Research Labs, LLC | f8730f9c-43c1-f4d3-e053-6294a90a1809 | 2024-12-19 | Warnings | M020 |
| Caribbean Breeze SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | f8735925-dcb2-6723-e053-6294a90a51f4 | 2024-12-19 | Warnings | M020 |
| Caribbean Breeze SPF 70 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | f873c125-86b8-3d1d-e053-6394a90a6bcf | 2024-12-19 | Warnings | M020 |
| Royal Boost Cover Me Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | efd7d887-0616-4c76-84d8-5370eb63cb7f | 2024-12-19 | Warnings | M020 |
| Rubber Ducky SPF 50 Unfragranced Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Derma Care Research Labs, LLC | 043b447c-4519-37ce-e063-6394a90a7197 | 2024-12-19 | Warnings | M020 |
| Australian Sands SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | f886a02f-c043-b281-e053-6294a90af746 | 2024-12-19 | Warnings | M020 |
| SPF 50 Sunscreen Rocky Mountain | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | a1c9066c-4801-5aee-e053-2995a90a75d2 | 2024-12-19 | Warnings | M020 |
| Dr. Throwers SPF 30 Face and Body Sunscreen | AVOBENZONE 3%, HOMOSALATE 12%, OCTISALATE 5%, OCTOCRYLENE 3% | Derma Care Research Labs, LLC | d680b6f6-e1a9-47a4-e053-2a95a90ae3b0 | 2024-12-19 | Warnings | M020 |
| Vacation Broad Spectrum SPF 30 | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | Vacation Inc. | 29a7636c-4d99-2cac-e063-6394a90a7480 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CARAMEL | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 29a82ba9-c0f8-0edf-e063-6294a90a50b4 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLE | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 29a8812b-70ff-e8aa-e063-6294a90a09f8 | 2024-12-19 | Warnings | M020 |
| CLE CCC Neutral Deep | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE | KW ABSC, INC. | 3a548deb-3670-4c5b-a139-796701801fed | 2024-12-19 | Warnings | M020 |
| CLE CCC Olive Medium Deep | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | be4434c0-cbdd-46cb-8015-4c7859e80d4a | 2024-12-19 | Warnings | M020 |
| CLE CCC Golden Medium | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | de50e956-a014-4147-922b-63c95fa6f86b | 2024-12-19 | Warnings | M020 |
| CLE CCC Neutral Light | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | 44cbb226-83ed-401b-baf8-ca8e4740dbef | 2024-12-19 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85366-204-60 | 85366020460 | 60 g in 1 BOTTLE, PUMP (85366-204-60) | 60 g | 2023-05-02 | No | No | Current |