Untinted Sheer Defense
- Product NDC
- 85516-202
- 11-digit product format
- 855160202
- Labeler code
- 85516
- Product ID
- 85516-202_46042d20-dc41-fe77-e063-6394a90a94aa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Kristina Lerner
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-05
- Substance
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 38; 80 mg/g; mg/g
- 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
- Untinted Sheer Defense
- 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 |
|---|---|
| 35be50b7-a9af-29ee-e063-6394a90a45ba | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85516-202-50 | Untinted Sheer Defense | 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 29W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247d6c0e-8f88-faf0-e063-6394a90a10da | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1e9a5c77-7027-3b52-e063-6394a90ac0eb | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e8241828-17b2-96c5-e053-2a95a90a12e5 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 1176181b-1331-ba68-e063-6394a90a961a | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247b56ad-4b61-8b6f-e063-6394a90af3b6 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247afcae-855e-3f69-e063-6394a90a4231 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 24306304-4d0d-c5f0-e063-6394a90afad5 | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACK | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1f9c7718-6fde-236c-e063-6394a90afa19 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3482855b-de85-a5a7-e063-6294a90a55ae | 2025-12-09 | Warnings | M020 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85516-202-50 | 85516020250 | 53 g in 1 BOTTLE, PUMP (85516-202-50) | 53 g | 2025-05-05 | No | No | Current |