Home NDC 61352-004-01 Total Sun Protection
Product NDC 61352-004
Requested package NDC 61352-004-01
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 113 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join UV Defense Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC 365e09a8-308b-b753-e063-6394a90ae9e5 2025-12-16 Exact identifier application number: M020 UV Defense Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC 365e2498-7df2-f22c-e063-6294a90ac6ab 2025-12-16 Exact identifier application number: M020 UV Protection Veil Mineral Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE ATHENA PLASTIC SURGERY 3b3bf5a6-33ec-0255-e063-6294a90ac96a 2025-12-16 Warnings Exact identifier application number: M020 UV Protection Veil Mineral Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE ATHENA PLASTIC SURGERY 3b3cba2e-acc6-a2df-e063-6294a90abf71 2025-12-16 Warnings Exact identifier application number: M020 Color Smart Tinted Mineral ZINC OXIDE MEGAN YORK INC. 365c4623-94d5-e8b6-e063-6394a90a966a 2025-12-16 Exact identifier application number: M020 Anti-Aging Tinted Sunscreen ZINC OXIDE KARINA SALDIVAR 3bca508e-7bd0-d45d-e063-6394a90a1730 2025-12-16 Warnings Exact identifier application number: M020 UV Protection Veil Mineral Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE ATHENA PLASTIC SURGERY 3b3c757f-6581-4978-e063-6294a90a6173 2025-12-16 Warnings Exact identifier application number: M020 Kind Restore Tinted Mineral Sunscreen ZINC OXIDE POLISH BEAUTY 3980810f-58b5-3a60-e063-6294a90a9c07 2025-12-16 Exact identifier application number: M020 Daydream Beyond Screen ZINC OXIDE ULTRAVIOLET SKINCARE LLC 36bfd963-d123-0d25-e063-6294a90aa827 2025-12-16 Exact identifier application number: M020 Virgo SOL Primer Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ULTRAVIOLET SKINCARE LLC 369d4f43-8c57-9fcf-e063-6294a90aa916 2025-12-16 Exact identifier application number: M020 Virgo SOL Non Tinted Mousse TITANIUM DIOXIDE, ZINC OXIDE ULTRAVIOLET SKINCARE LLC 369d63a9-b9ab-9530-e063-6394a90ac8ef 2025-12-16 Exact identifier application number: M020 Kind Restore Tinted Mineral Sunscreen ZINC OXIDE POLISH BEAUTY 3980d278-c0f4-2c59-e063-6394a90aac37 2025-12-16 Exact identifier application number: M020 Solar Eclipse Extreme Sunscreen ZINC OXIDE ULTRAVIOLET SKINCARE LLC 36bfa691-48c0-8033-e063-6294a90ad899 2025-12-16 Exact identifier application number: M020 Kind Restore Moisturizing Lip Balm TITANIUM DIOXIDE, ZINC OXIDE POLISH BEAUTY 39814e27-4f3f-5ee6-e063-6394a90a941b 2025-12-16 Exact identifier application number: M020 Yoali SPF 40 ZINC OXIDE YOALI STUDIO LLC 390b7f9c-bc04-80ec-e063-6294a90a4092 2025-12-16 Exact identifier application number: M020 Skin Defense Matte Tinted Sunscreen ZINC OXIDE Gentlehomme LLC 365eb727-3e7f-f1dd-e063-6394a90aa469 2025-12-16 Exact identifier application number: M020 Dr B Clinical Skin Care Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE NAIRA BABAIAN, M.D., P.A. 365da1f8-5250-7589-e063-6294a90a3e68 2025-12-16 Exact identifier application number: M020 Dr B Clinical Skin Care Non Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE NAIRA BABAIAN, M.D., P.A. 365d7564-3025-257b-e063-6294a90ad170 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE Gentlehomme LLC 365e7d8e-e3e0-4c08-e063-6294a90af415 2025-12-16 Exact identifier application number: M020 Daily Replenish mineral sunscreen ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 369896b1-f4b4-6201-e063-6394a90a5bca 2025-12-16 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