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 227 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vacation SPF 50 Super Spritz Face Mist	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f67fbe98-93ce-2882-e053-2a95a90ab713	2025-02-20	Warnings	Exact identifier application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	10edc0c1-9359-4c7a-a56e-bad06fea0056	2025-02-20	Warnings	Exact identifier application number: M020
Mineral SPF 30 Brush-On Sun Defense	ZINC OXIDE	Mineral Fusion	29733dba-8824-461e-be44-335d6fe50d60	2025-02-19	Warnings	Exact identifier application number: M020
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20cd4d96-2046-3a50-e063-6394a90a1219	2025-02-18	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 30 Pina Colada	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	edc59de7-c817-1a59-e053-2995a90a3408	2025-02-17	Warnings	Exact identifier application number: M020
Liplux SPF 30 Lip Balm	CLASSIC	COOLA LLC	b47b5f3a-43f3-ae7a-e053-2995a90ae16d	2025-02-17	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 50 Fragrance Free	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed207afe-0b10-74c7-e053-2a95a90a9b87	2025-02-17	Warnings	Exact identifier application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent Sunscreen	OCTINOXATE, OXYBENZONE, OCTISALATE	The Avon Company	2e5d6c93-f091-5388-e063-6394a90ad560	2025-02-17	Warnings	Exact identifier application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	31a98dc7-4b99-d845-e063-6394a90a2670	2025-02-17	Warnings	Exact identifier application number: M020
Ultra sheer mineral sunscreen PRO SPF30	ZINC OXIDE	Eden Brands Inc.	2ce06566-2eb0-9a00-e063-6394a90a9ba9	2025-02-14	Warnings	Exact identifier application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	CMS LAB Inc.	2dff0386-e151-089a-e063-6394a90a0f53	2025-02-14	Warnings	Exact identifier application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CMS LAB Inc.	2dffc699-3b56-2c70-e063-6294a90ae249	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Sheer)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2082aa-5ae3-2c04-e063-6294a90a140b	2025-02-14	Warnings	Exact identifier application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance Free	ZINC OXIDE	COOLA, LLC	edc6048e-0ea0-41c5-e053-2a95a90a96d9	2025-02-14	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 50 Guava Mango	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed13afaa-35ec-8326-e053-2995a90adaf0	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Light)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e21f5bb-e7df-b43b-e063-6394a90a0f82	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Fair)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2102c6-02ea-3a8f-e063-6394a90abf5e	2025-02-14	Warnings	Exact identifier application number: M020
Sunscreen Broad Spectrum SPF 50 Vi Aesthetics	ZINC OXIDE, OCTINOXATE	Vi Medical Products, INC	73620765-c7c0-4bd7-82a9-00022773c928	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Medium)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2297d4-3649-a749-e063-6294a90ac284	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Light)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e22cfde-10a1-3742-e063-6394a90ac097	2025-02-14	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