Home NDC 16555-008 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 table Ingredient Strength TITANIUM DIOXIDE 63 mg/mL ZINC OXIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table 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 table 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.
Matched openFDA labels page 109 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bella Blue Skin Care Tinted Sunscreen ZINC OXIDE BELLA BLU STUDIOS INC 3f663fe5-fdfe-d793-e063-6394a90a4f0b 2025-12-17 Warnings Exact identifier application number: M020 Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3aadc018-edbb-033b-e063-6394a90afbe7 2025-12-17 Warnings Exact identifier application number: M020 Non-Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3ab0298d-b2d0-591e-e063-6394a90a3177 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3cce3120-748e-a7fd-e063-6394a90a4d51 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3ccea6c0-8c27-6b26-e063-6294a90a0931 2025-12-17 Warnings Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE JKH Aesthetics LLC 369c1d16-5980-e1dc-e063-6394a90a3104 2025-12-17 Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3d5a2662-02e3-3a95-e063-6294a90a8120 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3d5ab3f6-10b9-2a21-e063-6294a90a3428 2025-12-17 Warnings Exact identifier application number: M020 Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JKH Aesthetics LLC 369ccb8f-d9b6-1fd2-e063-6394a90ace20 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364cafdd-fe86-cb23-e063-6394a90afb09 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364d2231-3db3-0a59-e063-6394a90a6777 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d4f6a7-1115-1efa-e063-6294a90a20c4 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d69eb5-597d-14a0-e063-6394a90a0a49 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d45700-fc41-ef54-e063-6394a90abcc3 2025-12-17 Exact identifier application number: M020 Gentle Mineral SPF 40 Tinted ZINC OXIDE ELIZA ARAKELIAN 36d66cde-1f90-32b5-e063-6294a90acb34 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d7148b-b1c4-a6a9-e063-6294a90af92f 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d85902-fbd2-ba74-e063-6294a90acfc3 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad1330-a8bf-e8f8-e063-6394a90acb02 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d9a8f3-7760-57f3-e063-6394a90a1a1e 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d7a18b-5a12-84a9-e063-6394a90a7e38 2025-12-17 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table 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