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 154 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATTITUDE Super Leaves Lip Balm SPF15 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ff1fc0-9ac5-2c9a-e063-6294a90a4632	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Coconut	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ff5675-fd8d-b665-e063-6294a90a1e0b	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Pineapple	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ffb35b-80f4-7ddb-e063-6394a90a2cbb	2025-12-02	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	44ffd469-0205-846f-e063-6294a90af6b5	2025-12-02	Warnings	Exact identifier application number: M020
COSRX	VITAMIN E VITALIZING SUNSCREEN	COSRX inc.	daf0291e-770c-eaf2-e053-2a95a90a0b67	2025-12-01	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Dewy Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE	70541	44e0098c-170f-ca51-e063-6294a90aed20	2025-12-01	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Sun Essence	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	70541	44e194cd-ea61-71b3-e063-6394a90ac486	2025-12-01	Warnings	Exact identifier application number: M020
Venture Performance Sun Protection Mineral Sunscreen SPF 50	ZINC OXIDE	Venture Performance Inc	630fc5c2-a315-4e26-9bd9-5f8533d75908	2025-12-01	Warnings	Exact identifier application number: M020
EMINENCE Red Currant Protective Moisturizer	OCTINOXATE, ZINC OXIDE	Eminence Organic Skin Care	7eca62af-6f70-44ec-879e-74712163c4e0	2025-12-01	Warnings	Exact identifier application number: M020
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer	AVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENE	Charlotte Tilbury Beauty Ltd.	2b215ecb-7c3a-63db-e063-6394a90aa88f	2025-12-01	Warnings	Exact identifier application number: M020
P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	LIFE WITHCORPORATION Inc.	44ea9fb4-8e01-6969-e063-6294a90a6a94	2025-12-01	Warnings	Exact identifier application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Rare Beauty Brands Inc.	44ec0db5-4437-e4a3-e063-6294a90a9a00	2025-12-01	Warnings	Exact identifier application number: M020
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RoC Skincare	2888a198-116b-8441-e063-6394a90a0f95	2025-12-01	Warnings	Exact identifier application number: M020
ReefSafe Very High Sun Protection sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ec619f-ed3b-2fd3-e063-6294a90a858b	2025-12-01	Warnings	Exact identifier application number: M020
Reef safe - Face and Body sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	38603298-e8da-e4c7-e063-6394a90aca3b	2025-12-01	Warnings	Exact identifier application number: M020
ReefSafe Baby and Toddlers Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44dd513e-ebaa-0d6a-e063-6394a90a78b7	2025-11-30	Warnings	Exact identifier application number: M020
Safe4Kidz Natural Mineral Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ddc0ae-a977-3adf-e063-6294a90a0898	2025-11-30	Warnings	Exact identifier application number: M020
Safe4Kidz Baby Zinc Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ddc4d8-3f3b-5d11-e063-6294a90ae88a	2025-11-30	Warnings	Exact identifier application number: M020
Clarite Makeup Foundation for a Clearer Appearance SPF 30 170-N	OCTINOXATE, ZINC OXIDE	BEL STAR S A	b56f5883-be57-e0e5-e053-2a95a90adb0c	2025-11-29	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Baby Mineral sunscreen Sprayer SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44a94a24-e292-41e6-e063-6394a90abe47	2025-11-28	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