Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55

Product NDC: 36800-167
11-digit product format: 368000167
Labeler code: 36800
Product ID: 36800-167_2487df86-039b-4d33-e063-6394a90acb50
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: TOPCO ASSOCIATES LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-24
Substance: OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE
Active strength: 70; 50; 100; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	36800-167		D	Discontinued by firm		2026-11-06
excluded package	package	36800-167	36800-167-08	D	Discontinued by firm		2026-11-06

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-167-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-167-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-167-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-167-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-167-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-167-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-167-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-167-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-167-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-167-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-167-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-167-08	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	70 mg/mL
OCTISALATE	50 mg/mL
HOMOSALATE	100 mg/mL
AVOBENZONE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
G63QQF2NOX	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
c6268778-8dcc-24b6-e053-2995a90acf03	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-167-09	Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55	89 mL in 1 TUBE	LOTION	89		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-167	TOPCARE EVERYDAY ULTIMATE SHEER SUN BROAD SPECTRUM SPF 55 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [TOPCO ASSOCIATES LLC]	2	Current NDC, Legacy NDC, 1 package rows	20241017_c6268778-8dcc-24b6-e053-2995a90acf03.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 272 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health SPF 70 Sun	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	63b420ba-ac69-5670-e053-2a91aa0a864b	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer SPF 100 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS PHARMACY	c52a7e9b-5401-f6e7-e053-2995a90a9519	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	c68c3d6a-b656-abaf-e053-2a95a90a48db	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 45 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	c5e8fcc9-db5c-9ee7-e053-2a95a90ac940	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 55 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	c617cdec-b489-22d2-e053-2995a90a1ec6	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ILLUMINATING DAILY FACIAL SUNSCREEN BROAD SPECTRUM SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	1b7c2f13-81b8-7af5-e063-6294a90a3501	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 50 Beach Guard	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	df25c35d-6b6d-1ef8-e053-2995a90aaef5	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Kids SPF 50 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	e4581d0e-ce6d-7898-e053-2a95a90a02b5	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 55 Ultra Sheer Face Mist	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	dfb55b46-e88f-4949-e053-2995a90adabc	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 30 Clear Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	CVS PHARMACY	e4589114-87c5-56b8-e053-2995a90a0934	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ENRICH MOISTURIZING FACE BROAD SPECTRUM SPF 15	OCTINOXATE, ZINC OXIDE	Trader Joe's Company	a6805675-916c-4a19-b993-d465fcef58a1	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES FACE AND BODY SUNSCREEN SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	057ac99c-60e8-47c1-a32d-984bbd181846	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ZINC OXIDE MINERAL SUNSCREEN SPF 30	ZINC OXIDE	Trader Joe's Company	9e48de83-cb72-4c03-a819-939db8793e1f	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES DAILY FACIAL SUNSCREEN SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	db3c2210-0e11-0a0e-e053-2a95a90aecbf	2024-10-22	Warnings	Exact identifier application number: M020
Philosophy Hope in a Jar Smooth-glow Multi-tasking Moisturizer Broad Spectrum SPF 30 with Pro-vitamin P, glycolic and hyaluronic acids	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Philosophy, Inc.	24ffeef6-ca72-5f30-e063-6394a90a41d1	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body BB Cream SPF 15 Natural	OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONE	Bali Body Pty Ltd	db0edf56-4f39-7b48-e053-2a95a90a9b42	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body Tinted Super Serum Natural SPF 30	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Bali Body Pty Ltd	f5eeaf37-33f2-2c0c-e053-2a95a90abcc0	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body BB Cream SPF 15 Tan	OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONE	Bali Body Pty Ltd	db0f6a36-27dd-3301-e053-2995a90aff65	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body Watermelon Tanning Oil SPF 6	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Bali Body Pty Ltd	03705641-feaf-2cbd-e063-6394a90a806e	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body Pineapple Tanning Oil SPF15	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Bali Body Pty Ltd	21c49bbf-97b1-c8c0-e063-6394a90ab412	2024-10-21	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-167-09	36800016709	89 mL in 1 TUBE (36800-167-09)	89 ml	2019-07-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topcare Everyday Ultimate Sheer Sun Lotion Broad Spectrum SPF 55	TOPCO ASSOCIATES LLC	2024-10-15	HUMAN OTC DRUG LABEL	2