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 135 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Repair Moisturizing Tinted ZINC OXIDE Skintique 37de5a51-0bc4-34ad-e063-6294a90a0eef 2025-12-11 Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE LEILANI VIDAL 36d51157-1bcd-79c8-e063-6394a90aba71 2025-12-11 Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE LEILANI VIDAL 36d4b998-c29c-ff89-e063-6394a90a12d8 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LEILANI VIDAL 36d5831a-7128-729a-e063-6394a90a8036 2025-12-11 Exact identifier application number: M020 Mineral Matte Non-Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ORAIOS BEAUTY LLC 3ac219bd-dfc8-fe22-e063-6394a90a4a8c 2025-12-11 Warnings Exact identifier application number: M020 Tinted Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ORAIOS BEAUTY LLC 3ac25d06-d885-48a2-e063-6294a90a0d0b 2025-12-11 Warnings Exact identifier application number: M020 Tinted Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ORAIOS BEAUTY LLC 3ac27b6c-1341-1f05-e063-6394a90a9860 2025-12-11 Warnings Exact identifier application number: M020 Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST 37287e4c-6fdf-62c5-e063-6394a90a1296 2025-12-11 Exact identifier application number: M020 Facial Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST 37284de3-32d4-3611-e063-6394a90a6393 2025-12-11 Exact identifier application number: M020 Mineral Lip Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST 3728ec6a-7de5-bbc5-e063-6294a90a31b7 2025-12-11 Exact identifier application number: M020 SUNerchi Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SYNERCHI MED SPA, INC. 37db5721-2b32-d4d8-e063-6294a90a47d7 2025-12-11 Exact identifier application number: M020 SUNerchi Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SYNERCHI MED SPA, INC. 37db14e1-f995-b649-e063-6294a90afd69 2025-12-11 Exact identifier application number: M020 208 ZINC OXIDE PETER L. KOPELSON, M.D. 351ce033-6bd0-574e-e063-6394a90af448 2025-12-11 Exact identifier application number: M020 208 ZINC OXIDE PETER L. KOPELSON, M.D., 351c9727-d7ac-9c3f-e063-6294a90a7721 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE MY FAVORITE PLACE SPA LLC 351c0c1e-5712-1e23-e063-6394a90abe6f 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Saving Face Skinspa Inc. 351d27e3-00d4-8d31-e063-6394a90aaf72 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Saving Face Skinspa Inc. 351db99e-262f-b67e-e063-6394a90a3418 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection NT ZINC OXIDE MY FAVORITE PLACE SPA LLC 351c5f6f-86e6-7219-e063-6294a90a3745 2025-12-11 Exact identifier application number: M020 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE DAISY'S SKIN TRANSFORMATION LLC 37d9fbf5-d602-d3dc-e063-6394a90abe53 2025-12-11 Exact identifier application number: M020 Tinted Mineral 40 TITANIUM DIOXIDE, ZINC OXIDE 2301 PLASTIC SURGERY, PLLC 374d53a7-be0b-4d7a-e063-6394a90a37c4 2025-12-11 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