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	2026-10-21
excluded package	package	36800-513	36800-513-12	D	Discontinued by firm	2026-10-21
excluded package	package	36800-513	36800-513-24	D	Discontinued by firm	2026-10-21

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 86 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROE WELLNESS SPF 50 MINERAL	SPF 50 MINERAL POWDER	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dc8155-4abb-4bb7-e063-6294a90af1ad	2026-01-08	Warnings	Exact identifier application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERAL	SUNSCREEN SPF50	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dd07aa-71b4-5d54-e063-6394a90a4127	2026-01-08	Warnings	Exact identifier application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45	SUNSCREEN SETTING SPRAY	Aopline Biotechnology (Guangzhou) Co., Ltd.	47ddf752-cae2-313f-e063-6294a90a7e3a	2026-01-08	Warnings	Exact identifier application number: M020
St Moriz suncare face sunscreen spf50	OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATE	Aopline Biotechnology (Guangzhou) Co., Ltd.	47df072e-151f-eb30-e063-6294a90a4eeb	2026-01-08	Warnings	Exact identifier application number: M020
SUNSCREEN GLOWING	AVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATE	Aopline Biotechnology (Guangzhou) Co., Ltd.	47df0de5-012a-c896-e063-6394a90a9cef	2026-01-08	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	616d35f6-63d2-3d26-e053-2991aa0a5b44	2026-01-08	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	616d35a1-a139-1974-e053-2a91aa0a20b6	2026-01-08	Warnings	Exact identifier application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral Sunscreen	SPF 30	EVI LABS	258b7b7c-a3f2-172c-e063-6394a90aec6a	2026-01-08	Warnings	Exact identifier application number: M020
DMK Ultrascreen Mineral Sunscreen	ZINC OXIDE	Danne Montague King	3f022275-c1e5-2704-e063-6294a90a4a81	2026-01-08	Warnings	Exact identifier application number: M020
Anhydrous SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68	2026-01-08	Warnings	Exact identifier application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer	REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER	Atlantic Medical Products, LLC	47e5198e-7bf6-72a8-e063-6294a90a7ec5	2026-01-08	Warnings	Exact identifier application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUM	INDE WILD SUN DEFENSE GLOW DROPS	INDE WILD PRIVATE LIMITED	47e57407-2925-09ca-e063-6294a90a49ec	2026-01-08	Warnings	Exact identifier application number: M020
NIDA Invisible Fit Sunscreen	SUNSCREEN	Proso Corp	47ed3b62-45ef-b67a-e063-6294a90a317b	2026-01-08	Warnings	Exact identifier application number: M020
Organic Matters SPF 50 Sunscreen	ZINC OXIDE	Veganic SKN Limited	12f37c8d-07f0-3e75-e063-6294a90a2cdf	2026-01-08	Warnings	Exact identifier application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50	ZINC OXIDE	Veganic SKN Limited	161a7209-10d8-928c-e063-6394a90a4139	2026-01-08	Warnings	Exact identifier application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and face	ZINC OXIDE	Veganic SKN Limited	1a97169e-67be-3d25-e063-6294a90a3b88	2026-01-08	Warnings	Exact identifier application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40	ZINC OXIDE	Dr. Loretta, LLC	1208d0f8-bb12-4574-b70e-3a76b11a64c7	2026-01-07	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	KDC/One Development Corporation, Inc.	259f3fe3-2967-6c05-e063-6394a90a9e45	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Extreme Zinc SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	4084dd98-357f-4011-b0d4-db6536d2931f	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Extreme Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	9b4acc5e-fdaf-4fcb-83a9-69e430dd43de	2026-01-07	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