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 149 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	34b8208b-7328-1891-e063-6294a90abdd9	2025-12-08		Exact identifier application number: M020
Protect Mineral Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	34b8dedc-0575-9819-e063-6394a90afebf	2025-12-08		Exact identifier application number: M020
Protect Mineral Stick Clear	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35bfa392-dfec-bd8a-e063-6394a90acffa	2025-12-08		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	34b9d646-e049-6781-e063-6294a90ab101	2025-12-08		Exact identifier application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen Non-Tinted	ZINC OXIDE	Melinda Menezes, M.D., Inc.	35be70d5-aefe-fd6f-e063-6394a90ac436	2025-12-08		Exact identifier application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen Tinted	ZINC OXIDE	Melinda Menezes, M.D., Inc.	35be17ce-c3a7-fd59-e063-6394a90ad11d	2025-12-08		Exact identifier application number: M020
Protect Mineral Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35c044a6-90be-55f8-e063-6294a90aad48	2025-12-08		Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUM	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247ed877-2926-1fd9-e063-6394a90aa153	2025-12-08	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL	OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE	Aekyung Industrial Co., Ltd.	11f1ad4c-af9a-c998-e063-6294a90a15db	2025-12-08	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TAN	OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE	Aekyung Industrial Co., Ltd.	11f37a57-47ce-4175-e063-6394a90a92ee	2025-12-08	Warnings	Exact identifier application number: M020
RECHARGE Protect Blur	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields Beauty, LLC	c787e3b9-33b1-4c47-95bd-b14cf6558938	2025-12-08	Warnings	Exact identifier application number: M020
Mineral Mist SPF-50	TITANIUM DIOXIDE, ZINC OXIDE	TUBBY TODD	dca54a19-af25-ce47-e053-2a95a90a22db	2025-12-07	Warnings	Exact identifier application number: M020
Inblair Elevate SPF15 Moisturizer	INBLAIR ELEVATE SPF15 MOISTURIZER	Guangzhou Fantesy Biotechnology Co.,Ltd	4567d413-d8cc-677b-e063-6294a90a1a42	2025-12-07	Warnings	Exact identifier application number: M020
HANCHOBIT Radiant Pink Tone Up Sun Cream	TITANIUM DIOXIDE	HANCHOYEANBIOTEC Co.,Ltd.	45685047-166d-8af5-e063-6294a90aa7be	2025-12-07	Warnings	Exact identifier application number: M020
EELHOE Moisturiser Sun Stick	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	454004c9-07fa-64ad-e063-6394a90a0c8a	2025-12-06	Warnings	Exact identifier application number: M020
OUHOE Daily Exposure Lightweight Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	454301b6-21a6-6153-e063-6294a90a1366	2025-12-06	Warnings	Exact identifier application number: M020
OUHOE Cotton Soft Sun Stick	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4543a43e-acf7-6759-e063-6394a90a2f53	2025-12-06	Warnings	Exact identifier application number: M020
OUHOE Centella Daily Sun	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4544f3a3-8c52-ea54-e063-6394a90a7a9c	2025-12-06	Warnings	Exact identifier application number: M020
EELHOE All Day Light Sunscreen Mist	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	45323ca3-c706-dcb5-e063-6394a90a96f7	2025-12-05	Warnings	Exact identifier application number: M020
EELHOE Airy Sunstick	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	45328c13-31ae-3bd2-e063-6394a90a814f	2025-12-05	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