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 291 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tanning Club Golden Glow Tanning Oil SPF-15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	TANNING CLUB, LLC	748a9933-02a3-48c1-8636-8f0468f66a13	2024-07-17	Warnings	Exact identifier application number: M020
Tan De Soleil Orange Tanning Balm SPF 6	HOMOSALATE, OCTISALATE	TANNING CLUB, LLC	5343f359-6074-467c-99bb-f08a7ca2df41	2024-07-17	Warnings	Exact identifier application number: M020
Tanning Club Tanning SPF-8	AVOBENZONE, OCTOCRYLENE	TANNING CLUB, LLC	bbf9d61e-f2e6-4fde-baad-c412091c60b6	2024-07-17	Warnings	Exact identifier application number: M020
Mackenzies SPF 40 Ocean Safe Sunscreen	ZINC OXIDE	Naturally Uncommon LLC	1c314b70-45a7-1bd1-e063-6294a90a0d6b	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Eucalyptus Mint SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d764eb8-a0a7-d034-e063-6394a90aef24	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Acai Berry SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d765c28-f9da-15b6-e063-6394a90a057f	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Banana Kiwi SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d76e972-4fc1-9438-e063-6294a90a5845	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Pineapple Twist SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d7699f4-3088-9436-e063-6294a90ab852	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Black Cherry SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d76824a-eac4-2d1f-e063-6294a90a8e66	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Classic Coconut SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d76aed7-308b-5cc5-e063-6394a90a4543	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Pink Watermelon SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d76e9b7-95af-6015-e063-6294a90a6f19	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Vanilla Creme SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d7713a9-de97-f0ff-e063-6294a90a8003	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Grapefruit SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d7723c7-984a-a789-e063-6394a90abdc4	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Matcha and Aloe SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d771406-7c59-6052-e063-6394a90a01e6	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Lemon Twist SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d770a10-a9fa-94c4-e063-6294a90a137a	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Mango SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d77866e-64f2-86d6-e063-6394a90a1292	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Peachy Peach SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d77c31e-c606-74b7-e063-6294a90a2cee	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Pink Lemon SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d77d785-56eb-e865-e063-6394a90acd01	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Pomegranate SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d77e9c3-cffd-0bb6-e063-6294a90aacd1	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix Strawberry Dragon Fruit SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d77f460-e7be-30fe-e063-6394a90a8f1e	2024-07-17	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