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 146 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Safe Sea SPF 50 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE NIDARIA TECHNOLOGY LTD 46641a33-d658-4ef0-9b7a-062adc401dde 2025-12-08 Warnings Exact identifier application number: M020 Skin Filter Glow SPF ZINC OXIDE MALORIE MILES 36485f44-a6bd-9529-e063-6294a90af7a4 2025-12-08 Exact identifier application number: M020 Skin Filter Matte SPF TITANIUM DIOXIDE, ZINC OXIDE MALORIE MILES 3647f983-9e75-8955-e063-6294a90af162 2025-12-08 Exact identifier application number: M020 Body-Screen ZINC OXIDE MALORIE MILES 36499be5-d680-92bf-e063-6394a90a89db 2025-12-08 Exact identifier application number: M020 Skin Filter Matte SPF TITANIUM DIOXIDE, ZINC OXIDE MALORIE MILES 3649f758-e31b-3c6a-e063-6294a90a5c36 2025-12-08 Exact identifier application number: M020 Body-Screen ZINC OXIDE MALORIE MILES 364ae392-480a-14ea-e063-6394a90a3883 2025-12-08 Exact identifier application number: M020 Personalized Moisturizer SPF 30 ZINC OXIDE 10.00% Proven Skincare d3cf8f81-d6ae-4570-ad86-43415e973e13 2025-12-08 Warnings Exact identifier application number: M020 GLOW SHIELD SPF ZINC OXIDE ACNE SOLUTIONS NYC INC 2f9d087c-b2b3-5654-e063-6294a90a94e5 2025-12-08 Warnings Exact identifier application number: M020 MATTE SHIELD SPF ZINC OXIDE ACNE SOLUTIONS NYC INC 2faee7ef-fc0c-6d01-e063-6294a90a6d68 2025-12-08 Warnings Exact identifier application number: M020 GLOW SHIELD SPF ZINC OXIDE ACNE SOLUTIONS NYC INC 2faf530d-5574-b702-e063-6294a90ad6fd 2025-12-08 Warnings Exact identifier application number: M020 MATTE SHIELD SPF ZINC OXIDE ACNE SOLUTIONS NYC INC 2fb00db0-4c37-56c6-e063-6294a90a8aff 2025-12-08 Warnings Exact identifier application number: M020 Matte Shield SPF TITANIUM DIOXIDE, ZINC OXIDE ACNE SOLUTIONS NYC INC 3bb582ec-71e7-4ad8-e063-6394a90a94d4 2025-12-08 Warnings Exact identifier application number: M020 SPF 101 Lightly Tinted ZINC OXIDE The Acne Lab LLC 334afdc8-1e12-d787-e063-6294a90aed7c 2025-12-08 Exact identifier application number: M020 SPF 101 Non-Tinted ZINC OXIDE The Acne Lab LLC 334bf8ea-2485-84e8-e063-6294a90aefa6 2025-12-08 Exact identifier application number: M020 SPF 101 Lightly Tinted ZINC OXIDE The Acne Lab LLC 334d694a-f9e4-ae86-e063-6394a90abfe1 2025-12-08 Exact identifier application number: M020 SPF 101 Non-Tinted ZINC OXIDE The Acne Lab LLC 334e32a4-c3a5-e37d-e063-6294a90ad6cf 2025-12-08 Exact identifier application number: M020 Mineral Based Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3245561d-a90c-7bf0-e063-6394a90ab3b6 2025-12-08 Exact identifier application number: M020 Mineral Based Sunscreen Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3245c1f7-2c1b-b6ad-e063-6394a90aaee6 2025-12-08 Exact identifier application number: M020 Mineral Based Facial Sunscreen ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3e8981ed-5847-7009-e063-6394a90a49a1 2025-12-08 Warnings Exact identifier application number: M020 Replenishing Daily Protection Sunscreen Invisible ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32462e88-0e74-a675-e063-6294a90ac564 2025-12-08 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