Beauty Hydrating

Product NDC: 36800-513
11-digit product format: 368000513
Labeler code: 36800
Product ID: 36800-513_4ab7966b-245e-3240-e063-6394a90a7338
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Topco Associates LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-02
Substance: HOMOSALATE; ZINC OXIDE
Active strength: 50; 30 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36800-513		D	Discontinued by firm	2026-10-28
excluded package	package	36800-513	36800-513-12	D	Discontinued by firm	2026-10-28
excluded package	package	36800-513	36800-513-24	D	Discontinued by firm	2026-10-28

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 · 36 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	36800-513-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-513-12	`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	36800-513-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-513-12	`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	36800-513-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-513-12	`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	36800-513-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-513-12	`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	36800-513-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-513-12	`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	36800-513-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-513-12	`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	36800-513-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-513-12	`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	36800-513-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-513-12	`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	36800-513-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-513-12	`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	36800-513-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-513-12	`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	36800-513-24	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-513-12	`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	36800-513-24	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-513-12	`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: Beauty Hydrating
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	50 mg/mL
ZINC OXIDE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	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
6e88ccc8-8576-4573-8a5b-28e64008a349	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
36800-513-30	Beauty Hydrating	1 in 1 PACKAGE	LOTION	1		37
36800-513-30	Beauty Hydrating	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-513	BEAUTY HYDRATING (HOMOSALATE, ZINC OXIDE) LOTION [TOPCO]	36	Current NDC, Legacy NDC, 2 package rows	20250519_6e88ccc8-8576-4573-8a5b-28e64008a349.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 151 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everyday Humans Sunscreen Lip Balm Broad Spectrum SPF30	LIP BALM SPF30	Everyday Group Limted	2d42034a-4ada-57cf-e063-6394a90a0b5f	2025-12-04	Warnings	Exact identifier application number: M020
Ciele SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen	SUNSCREEN 30 MINERAL	LE COSMETICS INC	3bb54b93-0ab2-2ecc-e063-6394a90acac3	2025-12-04	Warnings	Exact identifier application number: M020
Good Times SPF 50 Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	EVERYDAY GROUP LIMITED	f40c6c4a-47a2-5dfe-e053-2995a90a3df3	2025-12-04	Warnings	Exact identifier application number: M020
Sheer Guard Natural Mineral Sunscreen	ZINC OXIDE	EVERYDAY GROUP LIMITED	3257719d-dcc6-7ac5-e063-6294a90aafcd	2025-12-04	Warnings	Exact identifier application number: M020
Sun Glazed SPF 30 Sunscreen Glow Oil	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	EVERYDAY GROUP LIMITED	dba8075b-be36-4787-b23d-942d0e792aa8	2025-12-04	Warnings	Exact identifier application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Deep	ZINC OXIDE	Crunchi, LLC.	0dc478e0-9555-4ce6-b448-7d58e3a6bae0	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Shield SPF40	SOLBAR SHIELD SPF40	Person and Covey	bd3a9a94-fc87-4127-abf9-29e56ac9ce5d	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Thirty SPF 30	SOLBAR THIRTY SPF30	Person and Covey	ab9ac056-61d9-43d5-a3db-2d487897cc69	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Fifty SPF50	SOLBAR FIFTY SPF50	Person and Covey	41fd3844-181c-4cb2-8379-f313104351ef	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Avo SPF35	SOLBAR AVO SPF35	Person and Covey	bfe1e828-76d4-4db3-a8ba-b54b31baacad	2025-12-04	Warnings	Exact identifier application number: M020
Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip Balm	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	c7a3c03b-7fee-404c-e053-2a95a90a3a97	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Bronze Service Instant bronzing lotion. SPF30	HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	4524129b-f8aa-171b-e063-6294a90aeebe	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Zinc SPF38	SOLBAR ZINC SPF38	Person and Covey	fac62a2f-92ee-4afd-9999-bc5011159e43	2025-12-04	Warnings	Exact identifier application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl	ZINC OXIDE	e.l.f. Cosmetics, Inc.	6c316ce4-c2f6-4633-a789-e786d0f76abd	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen coconut SPF 15 Scented lip gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b5f2c-b61f-8915-e063-6294a90ac911	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip gloss	HOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b6e12-1bf9-8093-e063-6394a90a9e74	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip gloss	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b6f22-5080-86ab-e063-6394a90a0416	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Golden Hour SPF15 sunscreen lip oil	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b8393-1887-a660-e063-6394a90a4c2b	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gel	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b8dde-dd63-b585-e063-6394a90a3543	2025-12-04	Warnings	Exact identifier application number: M020
Binda Botanicals Baby and Kids Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	452b9b7d-4049-b483-e063-6394a90a5358	2025-12-04	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-513-30	36800051330	1 BOTTLE, PLASTIC in 1 PACKAGE (36800-513-30) / 177 mL in 1 BOTTLE, PLASTIC	2020-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care 043.000/043AA Original Beauty Lotion SPF 15	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	37