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 |
|---|---|---|---|---|---|---|
| Bath and Body Works SPF Coconut | AVOBENZONE,HOMOSALATE,OCTISALATE | Bath & Body Works, Inc. | 56078491-f7d6-97f7-e063-6394a90a6deb | 2026-07-07 | Warnings | M020 |
| Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxide | ZINC OXIDE | Surprise Enterprise LLC | 38cf4325-9720-f511-e063-6394a90ad628 | 2026-07-07 | Warnings | M020 |
| Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 560c0f35-2132-52a6-e063-6394a90a2d24 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Bonnie | CIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIE | Delicate Cosmetics Inc | 560d1d19-87a6-179b-e063-6294a90ada5e | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Kelly | CIELE LIP AND PROTECT LIPSTICK SPF 60 KELLY | Delicate Cosmetics Inc | 560df34a-e6da-0792-e063-6394a90a7e71 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 LouLou | CIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOU | Delicate Cosmetics Inc | 560e37ae-87c0-39d2-e063-6394a90a2af4 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Cassette | CIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTE | Delicate Cosmetics Inc | 560e4198-b07c-3d48-e063-6394a90a7be3 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Margaux | CIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUX | Delicate Cosmetics Inc | 560e47d5-c881-438c-e063-6394a90a3091 | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Saddle | CIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLE | Delicate Cosmetics Inc | 560e5de5-1350-4046-e063-6394a90abffa | 2026-07-07 | Warnings | M020 |
| Ciele lip and PROTECT lipstick SPF 60 Puzzle | CIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLE | Delicate Cosmetics Inc | 560e5558-8e46-7736-e063-6294a90acb05 | 2026-07-07 | Warnings | M020 |
| EELHOE Body Coverage Perfector | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 5610c3b7-456b-3bc1-e063-6394a90a3fa8 | 2026-07-07 | Warnings | M020 |
| Sunscreen SPF 50 | AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% | Worthy Promotional Products | 1d4be26a-4695-491c-85d1-86824e1cd029 | 2026-07-06 | Warnings | M020 |
| SPF 30 Sunscreen | HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3% | Coconut Caliente Costa Rica LLC | 71856cb3-9386-4569-80e4-92826342e386 | 2026-07-06 | Warnings | M020 |
| Stay Ageless Sunscreen | BROAD SPECTRUM SPF 30 | TOXFAIRY, LLC | 55f7e07e-1689-6d38-e063-6294a90a9119 | 2026-07-06 | Warnings | M020 |
| Premier Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Emerald Aesthetics LLC | 55f88dd1-346c-22a5-e063-6294a90a711f | 2026-07-06 | Warnings | M020 |
| RR Sun | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Undefined Inc | 87244432-2967-4145-89cd-11a7567083a3 | 2026-07-06 | Warnings | M020 |
| TOCOBO Cotton Airy Sun Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON CO., Ltd. | 35af90d3-dfe1-30dc-e063-6294a90a10a5 | 2026-07-05 | Warnings | M020 |
| MDP PEPTIDE 9 BIO SUN PRO | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | SKINIDEA CO., LTD | 26db53cd-dd82-8790-e063-6394a90a92b1 | 2026-07-03 | Warnings | M020 |
| SPF 50 plus Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Theravita LLC | d8e276cc-0292-499d-9075-a83a2d3fafcc | 2026-07-02 | Warnings | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | The Kroger Co. | 5880b275-91fc-4589-a076-0e55409425d8 | 2026-07-02 | Warnings, Adverse reactions | 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 |