Tinted Mineral Sun Defense
- Product NDC
- 85581-203
- 11-digit product format
- 855810203
- Labeler code
- 85581
- Product ID
- 85581-203_4616601b-083c-f75b-e063-6394a90a1a19
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Helen's Haven
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-12-01
- 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
- Tinted Mineral Sun 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 |
|---|---|
| 36c465ea-979b-9474-e063-6394a90ab3f8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85581-203-50 | Tinted Mineral Sun Defense | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 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 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 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c6252f-56b8-9e3c-e063-6294a90aa12c | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c62e80-9ace-c1f2-e063-6294a90a5bfa | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c6864c-bc8e-e900-e063-6294a90a7a14 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c77b48-18fb-3efe-e063-6294a90ade4b | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c784ce-3a54-5416-e063-6294a90ac9a2 | 2025-11-17 | Warnings | M020 |
| Daily Essential Face Moisturizer | ZINC OXIDE | Solarium Brands LLC | 2a92edc1-04ac-3eda-e063-6294a90ad46d | 2025-11-17 | Warnings | M020 |
| Daily Essential Eye Cream | TITANIUM DIOXIDE, ZINC OXIDE | Solarium Brands LLC | 2a931d9f-4ba8-e3a5-e063-6294a90af780 | 2025-11-17 | Warnings | M020 |
| Daily Essential Lip Oil Blushing Nude | ZINC OXIDE | Solarium Brands LLC | 2a93998c-185b-9207-e063-6294a90ab0e9 | 2025-11-17 | Warnings | M020 |
| Solarium Daily Essentials Skin Perfecting Primer | ZINC OXIDE | Solarium Brands LLC | 302a02d1-3dc5-2745-e063-6394a90ab6d2 | 2025-11-17 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85581-203-50 | 85581020350 | 53 g in 1 BOTTLE, PUMP (85581-203-50) | 53 g | 2020-12-01 | No | No | Current |