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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

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 245 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	f8361aa8-c3ad-0c47-e053-6394a90a6ab0	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6807577-56a1-a40c-e053-2995a90a5935	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	0289088d-3316-c90c-e063-6294a90a69e0	2025-01-01	Warnings	Exact identifier application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	a4364c8d-8b74-130e-e053-2995a90ad1c1	2025-01-01	Warnings	Exact identifier application number: M020
b.tan Tropic Like Its Hot SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Marque of Brands Americas, LLC	bb15b1bc-cfc0-0bab-e053-2a95a90af5b3	2025-01-01	Warnings	Exact identifier application number: M020
Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD	TITANIUM DIOXIDE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	ff95a7b7-3cb4-41b0-866d-69361354a0bc	2025-01-01	Warnings	Exact identifier application number: M020
Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 SUNSCREEN	AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE	Obagi Cosmeceuticals LLC	84f0f1dd-13f2-49f5-89b3-fab175ac2564	2025-01-01	Warnings	Exact identifier application number: M020
NU-DERM HEALTHY SKIN PROTECTION SPF 35	OCTINOXATE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	cfb6a918-1403-4cf2-86d8-d66dd764bb6c	2025-01-01	Warnings	Exact identifier application number: M020
CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Laboratoires Clarins	c6dffe5c-5539-4e86-bf5e-b0e497eb9c88	2024-12-31	Warnings	Exact identifier application number: M020
Badger Adventure Sport Clear Mineral Sunscreen SPF 50	ZINC OXIDE	W.S. Badger Company, Inc.	d10290b4-3c8a-e0bb-e053-2995a90a9b6b	2024-12-31	Warnings	Exact identifier application number: M020
Badger BROAD SPECTRUM SPF 15 Lip Balm	ZINC OXIDE	W.S. Badger Company, Inc.	d506ac39-5019-1291-e053-2995a90a796a	2024-12-31	Warnings	Exact identifier application number: M020
Badger Kids Mineral Sunscreen Cream Broad Spectrum SPF 40	ZINC OXIDE	W.S. Badger Company, Inc.	d619d2b4-bae8-bc76-e053-2995a90a369b	2024-12-31	Warnings	Exact identifier application number: M020
Badger SPF 35 Kids Clear Face Stick	ZINC OXIDE	W.S. Badger Company, Inc.	d1038442-ec86-07e3-e053-2995a90ad6ab	2024-12-31	Warnings	Exact identifier application number: M020
Badger Baby Sunscreen Cream Broad Spectrum SPF 40	ZINC OXIDE	W.S. Badger Company, Inc.	d61acaa0-73ef-eccf-e053-2995a90ad940	2024-12-31	Warnings	Exact identifier application number: M020
Badger Broad Spectrum SPF 35 Active Face Stick	ZINC OXIDE	W.S. Badger Company, Inc.	d61b0dc8-3864-d5e3-e053-2a95a90ac02f	2024-12-31	Warnings	Exact identifier application number: M020
Badger Active SPF 30 Mineral Sunscreen	ZINC OXIDE	W.S. Badger Company, Inc.	e169289b-811c-6033-e053-2a95a90a6f2a	2024-12-31	Warnings	Exact identifier application number: M020
Badger Sport Mineral Sunscreen Cream Broad Spectrum SPF 40	ZINC OXIDE	W.S. Badger Company, Inc.	d60b1145-7c3e-3668-e053-2a95a90a2374	2024-12-31	Warnings	Exact identifier application number: M020
Badger Sport Clear Mineral Sunscreen SPF 40	ZINC OXIDE	W.S. Badger Company, Inc.	d5049a21-12c1-2efb-e053-2a95a90a2592	2024-12-31	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup Golden	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94c0a2-8a4c-39b9-e063-6394a90acf8c	2024-12-31	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup Light	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a948e37-0554-d953-e063-6394a90a75e6	2024-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clinicians Complex Total Sun Protection SPF 30+	Cosmed Dermaceuticals, Inc. \| Southeast Holdings Corp	2025-11-11	HUMAN OTC DRUG LABEL	7