Aloe Up

Product NDC: 13630-0257
11-digit product format: 136300257
Labeler code: 13630
Product ID: 13630-0257_ecf84130-55e6-fe21-e053-2a95a90ab08a
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octisalate, Avobenzone, Octocrylene
Dosage form: SPRAY
Route: TOPICAL
Labeler: Prime Packaging Inc.
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-10-25
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 25 g/mL; g/mL; g/mL; g/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	13630-0257		I	Inactivated by FDA		2026-10-21
excluded package	package	13630-0257	13630-0257-4	I	Inactivated by FDA		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 · 30 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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`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	13630-0257-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13630-0257-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13630-0257-4	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13630-0257-4	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13630-0257-4	2024-01-30	C162847	48780-1	1030e365-2ec9-111a-e063-dadaa90a10e2	Aloe Up Coco-mango Sunscreen Mist Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13630-0257-4	Aloe UpBroad Spectrum SPF 50 Sunscreen	184 mL in 1 CAN	SPRAY	184		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13630-0257	ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]	1	Legacy NDC, 1 package rows	20221109_ecf7a2a2-6a43-2e1c-e053-2a95a90aec90.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 106 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TAN	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	85f3dd47-4f1f-4fa3-a171-4f4b7707191c	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	4e5764f3-9d9e-460b-ab1e-36f280281dec	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	e700dc6e-e7ae-47ee-9974-430bfd045b4f	2025-12-19	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TAN	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	c7924d60-03fb-4a4d-b718-e324f6f1f65f	2025-12-19	Warnings	Exact identifier application number: M020
THE GOLDEN GUARD Browning Radiance Gel Suncare for Body	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	4654c417-faa3-23c6-e063-6394a90a2b5a	2025-12-19	Warnings	Exact identifier application number: M020
THE MINERAL MELT Invisible Mineral Suncare for Face	TITANIUM DIOXIDE, ZINC OXIDE	Dune Suncare, Inc.	46557319-7546-e712-e063-6394a90a3cfe	2025-12-19	Warnings	Exact identifier application number: M020
Sand Cloud Mineral Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Sand Cloud Holdings, LLC	ff477199-9b01-fc90-e053-6294a90a5102	2025-12-19	Warnings	Exact identifier application number: M020
Sand Cloud Mineral Sunscreen For Face	TITANIUM DIOXIDE AND ZINC OXIDE	Sand Cloud Holdings, LLC	ff2346c6-d911-87b3-e053-6394a90ac6f8	2025-12-19	Warnings	Exact identifier application number: M020
Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - Shell	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	12c63195-8707-4df0-a4d3-6f31c543db7a	2025-12-19	Warnings	Exact identifier application number: M020
EltaMD UV SPF35	OCTINOXATE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	3029d6ed-a60b-4789-a567-d09b12d76bf4	2025-12-19	Warnings	Exact identifier application number: M020
OUHOE Universal Colored Moisturizer	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	4634fdcd-6f0e-25ca-e063-6294a90a196e	2025-12-18	Warnings	Exact identifier application number: M020
SUNSCREEN SPRAY150mL	ZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%	Foshan Sugar Max Cosmetics CO.,Ltd	4635f90a-bbc9-0676-e063-6394a90a9f35	2025-12-18	Warnings	Exact identifier application number: M020
Sunscreen Stick	HOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	4637503c-46dc-68de-e063-6394a90abdc7	2025-12-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e78c9ae0-c2ef-12ce-e053-2995a90abf1c	2025-12-18	Warnings	Exact identifier application number: M020
NARS PURE RADIANT TINTED MOISTURIZER Cuzco	OCTINOXATE, TITANIUM DIOXIDE	NARS Cosmetics	5bb5d035-16d9-4843-b9aa-d30730c88508	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	248be719-edff-f40d-e063-6394a90a4ef6	2025-12-18	Warnings	Exact identifier application number: M020
Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	59187729-c166-58fe-e053-2991aa0abe47	2025-12-18	Warnings	Exact identifier application number: M020
GM Collin SPF 25 UVA - UVB Urban Protection Veil Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	Laboratoires Dermo-Cosmetik Inc.	4f0d44ca-09f0-4feb-b78c-77d83e75d4e2	2025-12-18	Warnings	Exact identifier application number: M020
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	60a304b1-eee5-408b-e053-2a91aa0a0a08	2025-12-18	Warnings	Exact identifier application number: M020
THE BOD GUARD Invisible Gel Sunscreen for Body	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	463fa1ef-d40d-d818-e063-6294a90a5e61	2025-12-18	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13630-0257-4	13630025704	184 mL in 1 CAN (13630-0257-4)	184 ml	2017-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aloe Up Coco-mango Sunscreen Mist Broad Spectrum SPF 50	Prime Packaging Inc. \| Prime Enterprises Inc.	2022-11-08	HUMAN OTC DRUG LABEL	1