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 226 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOLA Firming Face Serum Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM	COOLA LLC	85fd7ef4-ed08-4a69-8293-5f3f3d264c04	2025-03-06	Warnings	Exact identifier application number: M020
GOLDEN HOUR HYDRATING SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	090b5861-20f5-43c6-aff6-d17d61e8568e	2025-03-04	Warnings	Exact identifier application number: M020
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50	ZINC OXIDE	Kenvue Brands LLC	bbd6710f-a665-437e-b86b-437f732984d1	2025-03-04	Warnings	Exact identifier application number: M020
LBEL DIVINE DOUBLE USE LONGWEAR 36H SPF 15 CREME 110	OCTINOXATE, ZINC OXIDE	BELSTAR S.A.	2f8607c5-b5ab-ed81-e063-6394a90a3453	2025-03-04	Warnings	Exact identifier application number: M020
ADVANCED PROTECTION SUNSCREEN SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	BOTANICAL SCIENCE, INC.	2f8bbd08-d199-03bd-e063-6294a90adfac	2025-03-04	Warnings	Exact identifier application number: M020
MINERAL TINTED SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BOTANICAL SCIENCE, INC.	2f9e2252-fb54-363f-e063-6294a90aa7c9	2025-03-04	Warnings	Exact identifier application number: M020
LBEL LUMI-AGE ANTI-AGING HYDRATING DAY FACIAL SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR S.A.	2f717492-347d-5bf8-e063-6294a90a4b5f	2025-03-03	Warnings	Exact identifier application number: M020
CoTZ Kids Mineral Sun Stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	2f7225d0-ddfa-e19a-e063-6294a90a52a8	2025-03-03	Warnings	Exact identifier application number: M020
Sum 37 Micro Active Daily Moisture Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	2eea94e1-2409-8ad6-e063-6294a90a5df8	2025-03-03	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Fair)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e21c9f9-acf8-997b-e063-6394a90ada3f	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Medium)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e232e8d-4274-68bc-e063-6394a90a942b	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Deep)	ZINC OXIDE	Eminence Organic Skin Care	2e23d463-fbc1-5718-e063-6294a90a7272	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Deep)	ZINC OXIDE	Eminence Organic Skin Care	2e24391f-4982-efae-e063-6394a90accaa	2025-03-01	Warnings	Exact identifier application number: M020
FRUDIA Blueberry Hydrating Air Fit Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	WELCOS CO.,LTD.	8b2a1baa-e528-48d6-9cd8-c3cb55e0641b	2025-02-28	Warnings	Exact identifier application number: M020
BRUSH ON BLOCK SPF 50 MINERAL	ZINC OXIDE	SPF Ventures, LLC	2f1b5454-8bf5-b447-e063-6394a90a743a	2025-02-27	Warnings	Exact identifier application number: M020
Clear Defense SPF 45	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	d681d92f-3501-4fca-b629-096341f20ab1	2025-02-27	Warnings	Exact identifier application number: M020
HA Physical Tint SPF 44	ZINC OXIDE, TITANIUM DIOXIDE	Private Label Skin Care	a5e19d77-703e-41e0-9a02-19227dc6c819	2025-02-27	Warnings	Exact identifier application number: M020
Physical Daily Defense Broad Spectrum Sunscreen SPF 40	ZINC OXIDE	Private Label Skin Care	18444581-66a4-4eda-a8df-627fa3b4b98a	2025-02-26	Warnings	Exact identifier application number: M020
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILL	ZINC OXIDE/TITANIUM DIOXIDE	SPF Ventures, LLC	2f069114-9ca8-aed4-e063-6394a90a46d8	2025-02-26	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Cream	230 N	Melaleuca Inc.	2f133abb-cad2-2ac8-e063-6294a90aa480	2025-02-26	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