INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50
- Product NDC
- 16555-008
- 11-digit product format
- 165550008
- Labeler code
- 16555
- Product ID
- 16555-008_26a76872-0814-5d6f-e063-6394a90aa63e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- TITANIUM DIOXIDE and ZINC OXIDE
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- DARPHIN DIST.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-07-15
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 63; 40 mg/mL; mg/mL
- 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
- INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 63 mg/mL |
| ZINC OXIDE | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 91277514-4db0-4b40-b95a-3530cac711df | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 16555-008-01 | 2022-08-05 | C162847 | 48780-1 | e4f33bdf-a161-d8a0-e053-dadaa90a6e4e | INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 |
| 16555-008-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a161-d8a0-e053-dadaa90a6e4e | INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16555-008-01 | INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 | 30 mL in 1 BOTTLE | LOTION | 30 | 9 | |
| 16555-008-01 | INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 | 1 in 1 CARTON | LOTION | 1 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 16555-008 | INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [DARPHIN DIST.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241114_91277514-4db0-4b40-b95a-3530cac711df.zip |
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 |
|---|---|---|---|---|---|---|
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 34b8208b-7328-1891-e063-6294a90abdd9 | 2025-12-08 | M020 | |
| Protect Mineral Sunscreen Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 34b8dedc-0575-9819-e063-6394a90afebf | 2025-12-08 | M020 | |
| Protect Mineral Stick Clear | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 35bfa392-dfec-bd8a-e063-6394a90acffa | 2025-12-08 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 34b9d646-e049-6781-e063-6294a90ab101 | 2025-12-08 | M020 | |
| Protect 20 Zinc Oxide Mineral Sunscreen Non-Tinted | ZINC OXIDE | Melinda Menezes, M.D., Inc. | 35be70d5-aefe-fd6f-e063-6394a90ac436 | 2025-12-08 | M020 | |
| Protect 20 Zinc Oxide Mineral Sunscreen Tinted | ZINC OXIDE | Melinda Menezes, M.D., Inc. | 35be17ce-c3a7-fd59-e063-6394a90ad11d | 2025-12-08 | M020 | |
| Protect Mineral Stick Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 35c044a6-90be-55f8-e063-6294a90aad48 | 2025-12-08 | M020 | |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUM | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247ed877-2926-1fd9-e063-6394a90aa153 | 2025-12-08 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL | OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE | Aekyung Industrial Co., Ltd. | 11f1ad4c-af9a-c998-e063-6294a90a15db | 2025-12-08 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TAN | OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE | Aekyung Industrial Co., Ltd. | 11f37a57-47ce-4175-e063-6394a90a92ee | 2025-12-08 | Warnings | M020 |
| RECHARGE Protect Blur | TITANIUM DIOXIDE, ZINC OXIDE | Rodan & Fields Beauty, LLC | c787e3b9-33b1-4c47-95bd-b14cf6558938 | 2025-12-08 | Warnings | M020 |
| Mineral Mist SPF-50 | TITANIUM DIOXIDE, ZINC OXIDE | TUBBY TODD | dca54a19-af25-ce47-e053-2a95a90a22db | 2025-12-07 | Warnings | M020 |
| Inblair Elevate SPF15 Moisturizer | INBLAIR ELEVATE SPF15 MOISTURIZER | Guangzhou Fantesy Biotechnology Co.,Ltd | 4567d413-d8cc-677b-e063-6294a90a1a42 | 2025-12-07 | Warnings | M020 |
| HANCHOBIT Radiant Pink Tone Up Sun Cream | TITANIUM DIOXIDE | HANCHOYEANBIOTEC Co.,Ltd. | 45685047-166d-8af5-e063-6294a90aa7be | 2025-12-07 | Warnings | M020 |
| EELHOE Moisturiser Sun Stick | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 454004c9-07fa-64ad-e063-6394a90a0c8a | 2025-12-06 | Warnings | M020 |
| OUHOE Daily Exposure Lightweight Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 454301b6-21a6-6153-e063-6294a90a1366 | 2025-12-06 | Warnings | M020 |
| OUHOE Cotton Soft Sun Stick | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 4543a43e-acf7-6759-e063-6394a90a2f53 | 2025-12-06 | Warnings | M020 |
| OUHOE Centella Daily Sun | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 4544f3a3-8c52-ea54-e063-6394a90a7a9c | 2025-12-06 | Warnings | M020 |
| EELHOE All Day Light Sunscreen Mist | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 45323ca3-c706-dcb5-e063-6394a90a96f7 | 2025-12-05 | Warnings | M020 |
| EELHOE Airy Sunstick | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 45328c13-31ae-3bd2-e063-6394a90a814f | 2025-12-05 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16555-008-01 | 16555000801 | 1 BOTTLE in 1 CARTON (16555-008-01) / 30 mL in 1 BOTTLE | 1 bottle | 2017-07-15 | 0000-00-00 | No | No | Current |