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	2026-10-27
excluded package	package	36800-513	36800-513-12	D	Discontinued by firm	2026-10-27
excluded package	package	36800-513	36800-513-24	D	Discontinued by firm	2026-10-27

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 144 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Non-Tinted Replenishing Daily Protection	ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	3699159a-3561-9ff6-e063-6394a90af9fd	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c1723-fb1d-ae3c-e063-6294a90a4609	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Satin Dewy Finish	ZINC OXIDE	TRU SKIN RITUALS	3249d05b-0f5c-4787-e063-6294a90aa0d7	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c3a18-ba8f-912d-e063-6394a90a2447	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c8641-1161-b8ac-e063-6394a90ae451	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Silk Matte Finish	TITANIUM DIOXIDE, ZINC OXIDE	TRU SKIN RITUALS	3248eb22-1e10-2091-e063-6394a90ad3e1	2025-12-09		Exact identifier application number: M020
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325cce54-a885-d586-e063-6394a90a90db	2025-12-09		Exact identifier application number: M020
Sheer Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TRU SKIN RITUALS	324acd75-9c38-4adc-e063-6394a90afa12	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Satin Dewy Finish	ZINC OXIDE	TRU SKIN RITUALS	324960e6-c1e7-d2b9-e063-6294a90a92ce	2025-12-09		Exact identifier application number: M020
Sol Purpose Mineral Sunscreen Tinted	ZINC OXIDE	TRU SKIN RITUALS	324a3475-07f0-033c-e063-6394a90a811a	2025-12-09		Exact identifier application number: M020
Perfect Sunscreen SPF 50 Sheer Mineral	ZINC OXIDE	Bluemercury, Inc.	d8f483ff-b990-40c5-b5b8-00065051ae7e	2025-12-09	Warnings	Exact identifier application number: M020
Foto Facial Age Delay Non-Tinted	TITANIUM DIOXIDE ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42674013-fa2b-42d7-e063-6294a90af999	2025-12-09	Warnings	Exact identifier application number: M020
Hydraboost Moisturizer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Bluemercury	eca867e6-4deb-4be2-ae3f-6850fb6223b3	2025-12-09	Warnings	Exact identifier application number: M020
Foto Facial Age Delay Matte Tinted	TITANIUM DIOXIDE ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42761919-8ae2-3c41-e063-6394a90abb8f	2025-12-09	Warnings	Exact identifier application number: M020
Dew Mineral	ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42f17245-92a9-3915-e063-6394a90a6817	2025-12-09	Warnings	Exact identifier application number: M020
Mineral Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c69b707-07ff-1a82-e063-6394a90a9fcd	2025-12-09	Warnings	Exact identifier application number: M020
Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c69f93f-0385-365c-e063-6394a90a12fd	2025-12-09	Warnings	Exact identifier application number: M020
Replenishing Daily Protection Tinted	ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c6a5601-a7a2-5e20-e063-6394a90a6643	2025-12-09	Warnings	Exact identifier application number: M020
Bronzing Blendrops Broad Spectrum SPF 40	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	124ca946-8412-4d6d-e063-6294a90a6338	2025-12-09	Warnings	Exact identifier application number: M020
Perfecting Blendrops Broad Spectrum SPF 40	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	12512cac-652e-b138-e063-6394a90ad1f2	2025-12-09	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