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		2026-11-03
excluded package	package	36800-167	36800-167-08	D	Discontinued by firm		2026-11-03

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 262 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Scar Cream w/SPF 30	AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6%	Walgreens	cc72c8c5-f3e9-e8e0-e053-2a95a90ae0b0	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ee9ae84b-c8fc-4a87-8910-46ec8ccfe1a9	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME AU GINSENG DORE SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	121aa873-5ca6-426b-8ece-dcb5a9f82a03	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	3421b9a3-6551-406f-af3a-b3da8a01d2b2	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN CC RED CORRECT SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Laboratoires M&L	21530925-03b7-40bb-9836-6ee4011c4a79	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	70a5537c-a364-4dae-8ab2-8ca0cbfd11b7	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	b55be8cb-7f21-45b0-bb8f-a60182077ca3	2024-12-11	Warnings	Exact identifier application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep Honey	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	dc792777-d8b6-3ebc-e053-2a95a90abc3f	2024-12-11	Warnings	Exact identifier application number: M020
Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen	ZINC OXIDE	Absolutely Natural	6e05e060-a531-4c4a-b273-889407ec5704	2024-12-11	Warnings	Exact identifier application number: M020
Peptide Lip Shine SPF30 Sunscreen	ZINC OXIDE	Colorescience, Inc.	98cdf19d-8b8a-4051-88bb-79160b2af39e	2024-12-11	Warnings	Exact identifier application number: M020
Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free Sunscreen	ZINC OXIDE	Absolutely Natural	082983a4-7b98-489d-8ac2-a185923b86ba	2024-12-11	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 50 Sunscreen	ZINC OXIDE	Absolutely Natural	89657538-904d-4908-ba7b-6f84706a8001	2024-12-11	Warnings	Exact identifier application number: M020
SISLEYA Global Anti-Age Hand care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE	C.F.E.B. Sisley	cddf11b1-a89b-4b54-b228-55ba8147f022	2024-12-10	Warnings	Exact identifier application number: M020
SUNLEYA Age minimizing sun care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	C.F.E.B. Sisley	67498d45-0871-4806-8854-81d3e50c4b90	2024-12-10	Warnings	Exact identifier application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	C.F.E.B. Sisley	1c774aa7-8963-4221-b4b0-b894bd1b941f	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep Amber	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	5599922a-b020-477c-a44c-1db42ec5756a	2024-12-10	Warnings	Exact identifier application number: M020
SUNLEYA Age minimizing sun care SPF 50 plus	AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE	C.F.E.B. Sisley	7c9fadaf-b961-4df0-89ae-87141b50b2c1	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen SPF 30 1-Natural	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	b3d53a10-2647-492a-a05f-b97c3f716aa8	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen SPF 30 2-Golden	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	389cbce6-552c-4633-babd-7b672632f0b9	2024-12-10	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	28f08236-1f01-d759-e063-6294a90adcfa	2024-12-10	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