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 300 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF30 Sunscreen Cariposa	TITANIUM DIOXIDE, ZINC OXIDE	Talent Brands Company LLC	37d696d9-f89d-498e-8fe9-1f08d05d7b61	2024-04-18	Warnings	Exact identifier application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 50	OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE	Galderma Laboratories, L.P.	6650d137-e69e-4ec2-8311-3de74bf21315	2024-04-17	Warnings	Exact identifier application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Berry SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Eco Lips. Inc.	e5e84e60-4339-460d-e053-2a95a90ad152	2024-04-17	Warnings	Exact identifier application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Mint SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Eco Lips. Inc.	e64c4a2d-134e-999a-e053-2a95a90a64ee	2024-04-17	Warnings	Exact identifier application number: M020
SPF 30 Mineral Sunscreen Cariposa	TITANIUM DIOXIDE, ZINC OXIDE	Talent Brands Company LLC	0bc21573-d302-4d85-8d8f-dca9a48e1f35	2024-04-17	Warnings	Exact identifier application number: M020
Differin Oil Absorbing Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	4d5978c7-3575-4b5b-97bd-5f3c89412baf	2024-04-17	Warnings	Exact identifier application number: M020
Cancer Council Everyday Active SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	16381c8f-f954-f0be-e063-6394a90ae401	2024-04-16	Warnings	Exact identifier application number: M020
The Nethercutt Collection Sunscreen Stick SPF 30 Broad Spectrum Sunscreen SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Eco Lips. Inc.	163a2994-d95a-5752-e063-6394a90aec5d	2024-04-16	Warnings	Exact identifier application number: M020
The Nethercutt Collection Hemp Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Eco Lips. Inc.	163ac1c1-7403-9d60-e063-6294a90a1cc0	2024-04-16	Warnings	Exact identifier application number: M020
Cetaphil	OCTOCRYLENE, AVOBENZONE	Galderma Laboratories, L.P.	2a6bc3f2-4e52-252b-d051-94be1ee0cc00	2024-04-16	Warnings	Exact identifier application number: M020
Cetaphil Oil Absorbing SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	73ed545b-460f-4287-8643-a02b0641fd45	2024-04-16	Warnings	Exact identifier application number: M020
SUN CONTROL BROAD SPECTRUM SPF 30	HOMOSALATE, OCTISALATE, ZINC OXIDE	SKINPLAN.US LLC	8e34a343-7253-469f-9973-076a7ae26cbc	2024-04-15	Warnings	Exact identifier application number: M020
Cancer Council Protect and Hydrate Radiance SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	1622c351-6e69-eeaf-e063-6294a90acd25	2024-04-15	Warnings	Exact identifier application number: M020
Hydrating Mineral Sunscreen BS SPF30	ZINC OXIDE	Allure Labs	16268c31-2151-20e0-e063-6294a90a7965	2024-04-15	Warnings	Exact identifier application number: M020
Cancer Council Daily Body Moisturizer SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	16296d3e-286a-e015-e063-6394a90a4189	2024-04-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	f9645435-e138-45df-a5ec-6dc7b3ff792d	2024-04-08	Warnings	Exact identifier application number: M020
Degil Sun SPF 50 Sunscreen	HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE	Degil Safety Products (1989) Inc	155aa0c5-6403-ee86-e063-6294a90a1c4d	2024-04-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip SPF 15 Assorted	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	ff9eae5b-4963-429d-bb73-8e3b5402f084	2024-04-05	Warnings	Exact identifier application number: M020
Lemongrass Spa Products SPF 45 Mineral Sunscreen	ZINC OXIDE	Lemongrass Spa Products	15469260-d4e5-8423-e063-6394a90aafae	2024-04-04	Warnings	Exact identifier application number: M020
Clearly Zinq Tinted Hydrating Facial SPF Growth Factor 35	ZINC OXIDE	Allure Labs	1548faf9-8623-f871-e063-6394a90a931f	2024-04-04	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