Tinted Mineral Sunscreen
- Product NDC
- 85318-203
- 11-digit product format
- 853180203
- Labeler code
- 85318
- Product ID
- 85318-203_45875797-5d3c-491e-e063-6294a90aed5d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Maloney Plastic Surgery Skin Care, PLLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-08-27
- Substance
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 38; 80 mg/g; 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 38 mg/g |
| TITANIUM DIOXIDE | 80 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 316b7584-c782-fe9e-e063-6394a90a76fe | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85318-203-50 | Tinted Mineral Sunscreen | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 2 |
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 |
|---|---|---|---|---|---|---|
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483e7e6-b301-136d-e063-6294a90aba18 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483e4fa-883b-fb9c-e063-6394a90adcc4 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483dd31-417b-01ba-e063-6294a90a83a8 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483e998-6122-fb84-e063-6394a90a159f | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | c96e691a-99e1-4cb4-aebf-7444f4a6865f | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | ab1c8e9e-fd8f-473e-8930-625706e8e9d6 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 17073264-ec02-4801-841d-86778debd8c4 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | caee5c88-1907-41c1-987e-5bc544267dca | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 973b70f1-ee59-4dd9-aca3-432d721204ab | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 208fe03e-384b-4599-a4d0-a553fba306da | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 279258dd-b3fa-47be-8540-66bd9c879fc5 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 4206b607-5c26-4c9d-ade7-58c9740cdbe8 | 2025-12-09 | Warnings | M020 |
| L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium | OCTOCRYLENE, ZINC OXIDE | L'BRI Health & Beauty | 949a2796-717c-4820-ae09-2636e3dd6e3d | 2025-12-09 | Warnings | M020 |
| L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium Dark | OCTOCRYLENE, ZINC OXIDE | L'BRI Health & Beauty | f9bbc6d3-eb50-4953-8dba-732094b4c7c4 | 2025-12-09 | Warnings | M020 |
| Safe Sea SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | NIDARIA TECHNOLOGY LTD | 53df3126-1136-490a-b339-5876ce89499e | 2025-12-09 | Warnings | M020 |
| Safe Sea SPF 50 kids | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | NIDARIA TECHNOLOGY LTD | 3fa04557-2bc1-4eb4-aed8-eacc79189613 | 2025-12-09 | Warnings | M020 |
| Safe Sea SPF 40 | OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | NIDARIA TECHNOLOGY LTD | c900b88b-1de1-4df9-af84-d9001e1d4764 | 2025-12-09 | Warnings | M020 |
| StriVectin ANTI-WRINKLE GLOWFECTOR SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | StriVectin Operating Company, Inc. | ed357e76-54a1-66bd-e053-2a95a90a1e2a | 2025-12-09 | Warnings | M020 |
| Non-tinted Physical Block Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Tucson Acne Clinic | 30dd2f6b-5dcc-b081-e063-6394a90ae5f1 | 2025-12-09 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85318-203-50 | 85318020350 | 53 g in 1 BOTTLE, PUMP (85318-203-50) | 53 g | 2021-08-27 | No | No | Current |