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 247 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Almay Healthy Biome Makeup	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	ab20969a-8640-307d-e053-2a95a90a004d	2024-12-30	Warnings	Exact identifier application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Exelencia importers Corp.	2a845e4c-86e7-1799-e063-6294a90a9b2b	2024-12-30	Warnings	Exact identifier application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15	OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENE	Revlon Consumer Products Corp	012be422-1b4c-443c-9484-02efc744296d	2024-12-30	Warnings	Exact identifier application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	REVLON	2a857553-5ad0-a0e2-e063-6294a90af435	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2035ab03-80b4-49f4-b379-eb8bc42c9cee	2024-12-30	Warnings	Exact identifier application number: M020
PRISMA PROTECT SPF30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	713bad2e-bf32-4cd5-9630-b8d88d437686	2024-12-30	Warnings	Exact identifier application number: M020
Protection 50 Sport	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	e9ace96a-7717-4f5a-8e1b-1f56f7498599	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	b137b3d0-212b-440a-b158-62ace4b4eff3	2024-12-30	Warnings	Exact identifier application number: M020
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	3a6db7d3-6c59-4633-a97e-1c03127246d3	2024-12-30	Warnings	Exact identifier application number: M020
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen	OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	df62e1c2-ce72-4ded-8985-156dce9ff41d	2024-12-28	Warnings	Exact identifier application number: M020
LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	02dddfc5-61e6-433b-8d6d-a17bf3fc8ed6	2024-12-28	Warnings	Exact identifier application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	229eef79-39ae-4395-8100-64d1ece960d2	2024-12-28	Warnings	Exact identifier application number: M020
COOLA Mineral Sun Silk Creme Sunscreen SPF 30	ZINC OXIDE	COOLA LLC	bb9dd9a9-ec01-4e94-9172-3a72e68a417a	2024-12-27	Warnings	Exact identifier application number: M020
Bare Republic Mineral SPF 50	ZINC OXIDE	COOLA LLC	6a0db9da-ee45-4ab7-80de-4bf189efe75f	2024-12-27	Warnings	Exact identifier application number: M020
COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	COOLA LLC	9a397a2c-4734-4dae-93dd-15c68e6c297d	2024-12-27	Warnings	Exact identifier application number: M020
Refreshing Water Hydration Stick SPF 50	AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE	COOLA LLC	6da037f8-bedb-467a-b534-e44752120f2c	2024-12-27	Warnings	Exact identifier application number: M020
Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	NSE Products, Inc.	649a9c28-bfd4-404c-90d5-5d0ea8c7b645	2024-12-27	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	87496037-36ca-4c5f-973f-46626cf4096e	2024-12-27	Warnings	Exact identifier application number: M020
PORESCREEN SPF40	ZINC OXIDE	Dermalogica, LLC.	37a7362a-b251-4d3a-a957-65d8f338fa12	2024-12-27	Warnings	Exact identifier application number: M020
COOLA Classic Face Sunscreen Fragrance-Free SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	12ff4689-f7e2-49db-8848-608c61b41ef0	2024-12-27	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