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 144 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Florida Babe SPORT Mineral Sunscreen Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Tichy Anesthesia PA	31f5bbe4-5f6e-3bef-e063-6294a90a2646	2025-12-09		Exact identifier application number: M020
Florida Babe SPORT Mineral Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Tichy Anesthesia PA	31f54a79-70b7-def5-e063-6294a90a709b	2025-12-09		Exact identifier application number: M020
Florida Babe Sport Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tichy Anesthesia PA	3231b71c-4d27-e5e2-e063-6294a90a031b	2025-12-09		Exact identifier application number: M020
Arbonne Soft Focus Veil Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Arbonne International, LLC	3c9b605b-5a16-4f89-a956-8c4c62de72d3	2025-12-09	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	364b9560-f7a1-ed8f-e063-6294a90a2c41	2025-12-09		Exact identifier application number: M020
Sunshield Moisturizing Sunscreen and Antioxidant	ZINC OXIDE	Oculofacial Surgery andCosmetic Laser Institute, LLC.	32c247fc-d4da-e03d-e063-6394a90a72b0	2025-12-09		Exact identifier application number: M020
SCALP SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	FOLICULE LLC	387b10e1-5443-7b7a-e063-6394a90a2c7a	2025-12-09		Exact identifier application number: M020
Sunshield Moisturizing Sunscreen and Antioxidant	ZINC OXIDE	Oculofacial Surgery andCosmetic Laser Institute, LLC.	32c3936e-4089-edd0-e063-6294a90ad3f8	2025-12-09		Exact identifier application number: M020
Tinted Replenishing Daily Protection	ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	364cf1f7-1f87-51f7-e063-6294a90a789c	2025-12-09		Exact identifier application number: M020
Non-Tinted Foaming Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	3698c076-68b1-7d28-e063-6394a90a517c	2025-12-09		Exact identifier application number: M020
Non-Tinted Replenishing Daily Protection	ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	3699159a-3561-9ff6-e063-6394a90af9fd	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c1723-fb1d-ae3c-e063-6294a90a4609	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Satin Dewy Finish	ZINC OXIDE	TRU SKIN RITUALS	3249d05b-0f5c-4787-e063-6294a90aa0d7	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c3a18-ba8f-912d-e063-6394a90a2447	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c8641-1161-b8ac-e063-6394a90ae451	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Silk Matte Finish	TITANIUM DIOXIDE, ZINC OXIDE	TRU SKIN RITUALS	3248eb22-1e10-2091-e063-6394a90ad3e1	2025-12-09		Exact identifier application number: M020
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325cce54-a885-d586-e063-6394a90a90db	2025-12-09		Exact identifier application number: M020
Sheer Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TRU SKIN RITUALS	324acd75-9c38-4adc-e063-6394a90afa12	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Satin Dewy Finish	ZINC OXIDE	TRU SKIN RITUALS	324960e6-c1e7-d2b9-e063-6294a90a92ce	2025-12-09		Exact identifier application number: M020
Sol Purpose Mineral Sunscreen Tinted	ZINC OXIDE	TRU SKIN RITUALS	324a3475-07f0-033c-e063-6394a90a811a	2025-12-09		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