Home NDC 61352-004 Total Sun Protection
Product NDC 61352-004
11-digit product format 613520004
Labeler code 61352
Product ID 61352-004_43545da6-6e83-7dc3-e063-6294a90ab889
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, Oxybenzone, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Cosmed Dermaceuticals, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-08-01
Substance OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE
Active strength 75; 30; 30; 40 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Total Sun Protection
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 75 mg/g OCTISALATE 30 mg/g OXYBENZONE 30 mg/g ZINC OXIDE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61352-004-01 Total Sun Protection 127.6 g in 1 BOTTLE, PLASTIC LOTION 127.6 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61352-004 TOTAL SUN PROTECTION (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) LOTION [COSMED DERMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20241210_dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f.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 117 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Total Eye 3-In-1 Renewal Therapy SPF 35 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 4b116cc4-94d2-4bfc-b7f9-5f486a194c6c 2025-12-16 Warnings Exact identifier application number: M020 Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32 ZINC OXIDE Onekind.25 c11197f4-cee0-04b3-e053-2995a90a1ba8 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium Deep ZINC OXIDE Crunchi, LLC. 69618265-2ebb-4cdc-a28f-e36c07fe5b8f 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium ZINC OXIDE Crunchi, LLC. 23248bc3-1b82-443a-b38a-df7f0efb5d2a 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light ZINC OXIDE Crunchi, LLC. cf4039f5-00ee-4227-a3dc-61995c800135 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Body Sunscreen SPF 30 ZINC OXIDE Crunchi, LLC. 227f5a41-8c3c-492d-947f-e2b046208bca 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light Medium ZINC OXIDE Crunchi, LLC. 5b3f2766-065b-4817-a5ff-bd1c7882bfc9 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Daily Facial Sunscreen SPF 30 ZINC OXIDE Cruchi, LLC. 4f3bcfa0-e43e-4284-afaa-6488ddd749f0 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543a22c-34d5-e572-e063-6394a90ad579 2025-12-15 Exact identifier application number: M020 Stellar Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb6488c-d216-8742-e063-6394a90a16e2 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb8ee19-81b2-daed-e063-6394a90a0fb3 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb6cfd4-fa4a-d1d9-e063-6394a90a8e43 2025-12-15 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 35442ac0-c361-e08f-e063-6294a90a5cb2 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543e85d-9bc7-b8ed-e063-6294a90ae7d3 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bc8593d-fc6c-04aa-e063-6394a90a6d56 2025-12-15 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE MANTRA WELLNESS SPA 338855fd-3008-44d9-e063-6294a90a5e07 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE MANTRA WELLNESS SPA 33898415-4ee6-a384-e063-6394a90ae8e1 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Mantra Wellness Spa 3389b0a3-40f9-b411-e063-6394a90a9959 2025-12-15 Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE Mantra Wellness Spa 338a11fb-24c6-8a0b-e063-6294a90a761e 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Mantra Wellness Spa 338aa5a2-29e3-fe0e-e063-6294a90a18fd 2025-12-15 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 61352-004-01 61352000401 127.6 g in 1 BOTTLE, PLASTIC (61352-004-01) 127.6 g 2018-02-13 0000-00-00 No No Current