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 105 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a8037741-ec57-43e7-adb4-2a93941ee108 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6f872199-067e-40aa-bf34-549ecc33b1ac 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 4f27a485-1e8b-4f34-99a8-0d0a3cf1b9db 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 938a5c4a-b9dd-4089-8b20-7030f032591d 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4C OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 1357ab72-0d73-41da-8f55-7bd6d97c9ae8 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2d63bdc5-5338-48c4-9c59-bfb9900ab920 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a315ed9c-bc19-40e9-85ab-50ac1daa5449 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a63ea887-cbe0-4a04-ad62-4d3a87ece113 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 15c50e40-b97d-4612-a533-cf9d1d57b417 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 63711abf-e906-4c07-bc2d-f8e10fead2f0 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 21455f0c-0190-4519-a8e3-34206d1f7a42 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 3894273d-c5e7-4ea8-9956-5ac3d88b7420 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3C OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8b63133c-150a-4290-a7fb-56b0dc42a8ce 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ae7ca27f-7806-452e-9935-4a4abc37a5eb 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 9bbacc16-8d60-4170-a3cb-0bfb748177a2 2025-12-19 Warnings Exact identifier application number: M020 Perricone MD NEUROPEPTIDE Rejuvenating Moisturizer SPF 25 Broad Spectrum SPF 25 ZINC OXIDE THG Beauty USA LLC 464e2d4e-9837-e6d5-e063-6294a90a726a 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 FAIR TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 4327c775-e179-47d8-9b4b-945fc1b0b234 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 LIGHT TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 0f3a9b6a-b1b2-4d69-88de-6f22c17a4844 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TAN TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 5cce7646-d9f5-454b-b7a8-a5a6b62a1916 2025-12-19 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICH TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 7da16dd7-c26c-4c4e-905f-3bbb878022cc 2025-12-19 Warnings 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