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 227 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRUSH ON BLOCK SPF 50 KIDS MINERAL	ZINC OXIDE	SPF Ventures, LLC	2f17b5fe-44da-964b-e063-6394a90ae699	2025-02-26	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Tan)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2efb73a6-601d-61a4-e063-6294a90af825	2025-02-25	Warnings	Exact identifier application number: M020
Rida Hair Research Institute	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Rida LLC	ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca	2025-02-25	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 70 Peach Blossom	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed217698-f552-677e-e053-2995a90acb0a	2025-02-25	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 30 Tropical Coconut	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed0f8249-aba8-b67c-e053-2a95a90af7eb	2025-02-25	Warnings	Exact identifier application number: M020
Hydro Essence Broad Spectrum Sunscreen SPF 40	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	f176c1b1-f539-417f-98b5-69d99365f2f2	2025-02-25	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Tan)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2ee82379-6609-fd8e-e063-6294a90acf6c	2025-02-24	Warnings	Exact identifier application number: M020
Vacation SPF 50 Classic	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f2780cb5-063c-10d3-e053-2995a90a8576	2025-02-24	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	2ee9b3dc-91cd-1af9-e063-6394a90a78e1	2025-02-24	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	2edc79f8-aac5-15eb-e063-6394a90a9736	2025-02-23	Warnings	Exact identifier application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C	OCTINOXATE, ZINC OXIDE	BEL STAR S A	dc25651b-0e30-c325-e053-2995a90a809e	2025-02-21	Warnings	Exact identifier application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-C	OCTINOXATE, ZINC OXIDE	BEL STAR S A	dc129cd6-a173-d2b3-e053-2a95a90aa04e	2025-02-21	Warnings	Exact identifier application number: M020
COOLA Classic Liplux Lip Balm SPF 30 Tinted	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	eec6e7c8-17fe-f34b-e053-2995a90a78a0	2025-02-20	Warnings	Exact identifier application number: M020
Drops	AVOBENZONE OCTISALATE OCTOCRYLENE	Vacation Inc.	1319d6ea-a580-79c5-e063-6394a90a4dca	2025-02-20	Warnings	Exact identifier application number: M020
Vacation SPF 50 Super Spritz Face Mist	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f67fbe98-93ce-2882-e053-2a95a90ab713	2025-02-20	Warnings	Exact identifier application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	10edc0c1-9359-4c7a-a56e-bad06fea0056	2025-02-20	Warnings	Exact identifier application number: M020
Mineral SPF 30 Brush-On Sun Defense	ZINC OXIDE	Mineral Fusion	29733dba-8824-461e-be44-335d6fe50d60	2025-02-19	Warnings	Exact identifier application number: M020
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20cd4d96-2046-3a50-e063-6394a90a1219	2025-02-18	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 30 Pina Colada	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	edc59de7-c817-1a59-e053-2995a90a3408	2025-02-17	Warnings	Exact identifier application number: M020
Liplux SPF 30 Lip Balm	CLASSIC	COOLA LLC	b47b5f3a-43f3-ae7a-e053-2995a90ae16d	2025-02-17	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