ALOE ICE

Product NDC: 61477-204
11-digit product format: 614770204
Labeler code: 61477
Product ID: 61477-204_497ad0ff-be39-2cf7-e063-6394a90a7274
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Aloe Care International, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-02-24
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 3; 10; 5; 2.75; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61477-204		D	Discontinued by firm		2026-10-21
excluded package	package	61477-204	61477-204-14	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 · 24 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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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	61477-204-14	`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: ALOE ICE
Brand name suffix: SPF 50
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	3 g/100mL
HOMOSALATE	10 g/100mL
OCTISALATE	5 g/100mL
OCTOCRYLENE	2.75 g/100mL
OXYBENZONE	4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
95OOS7VE0Y	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
e4b861d2-3680-4ed7-8650-d1d839da5ab2	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61477-204-26	2024-02-13	C162847	48780-1	0191ceaa-6899-198a-e063-dbdaa90aec3e	ALOE UP - ALOE ICE SPF 50 SPRAY (61477-204)
61477-204-26	2023-07-28	C162847	48780-1	0191ceaa-6899-198a-e063-dbdaa90aec3e	ALOE UP - ALOE ICE SPF 50 SPRAY (61477-204)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61477-204-26	ALOE ICESPF 50	177 mL in 1 BOTTLE, SPRAY	SPRAY	177		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61477-204	ALOE ICE SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20240214_e4b861d2-3680-4ed7-8650-d1d839da5ab2.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 64 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sport Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	6d1ad14e-afc6-4676-87d7-3e50e3a02fe9	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Babies SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	64766ed9-bd47-498d-bf59-fb30a7bf7e89	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Broad Spectrum Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	ccb651f6-e567-4c5f-9109-8767270cc4be	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	80dcd255-3a6c-4b79-b081-519c9dac990a	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Moisturizing Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Service, LLC	9de8b6b1-024b-4b71-96e6-fea68088d3ab	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	SUNSCREEN	Retail Business Services, LLC	96221c10-ebfe-4385-b6b5-d504258df36c	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Moisturizing Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	e2adbde9-3c8b-45f3-b4ef-4936b88d812d	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Sunkissed Glow	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	bf1a237b-b27e-4c55-8ded-e348240a5b9a	2026-02-06	Warnings	Exact identifier application number: M020
SEYTU Body Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Omnilife USA, Inc.	c411e9a6-b2ea-446b-a886-b92c61736e6c	2026-02-05	Warnings	Exact identifier application number: M020
SEYTU Facial Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Omnilife USA, Inc.	96fd37fb-c3ff-413f-b2c8-50754f320ecc	2026-02-05	Warnings	Exact identifier application number: M020
Sun Veil IlluminatingElixir Face Sunscreen SPF 38	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Koco Life LLC	4a15c479-d676-9e52-e063-6394a90a4eb4	2026-02-05	Warnings	Exact identifier application number: M020
Golden Sunglaze Sheer Body Mist Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	22d0a5db-6af1-a3ca-e063-6394a90a68ef	2026-02-05	Warnings	Exact identifier application number: M020
Sunglaze Sheer Setting Mist Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTYOCRYLENE	Koco Life LLC	22ce9b26-2bf8-c1ea-e063-6394a90a8ec2	2026-02-05	Warnings	Exact identifier application number: M020
Peppermint SPF 15 Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Naples Soap Company, Inc.	24adffd4-5177-f5d5-e063-6294a90a7850	2026-02-05	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Bamboo	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	ebfe03e7-614f-44b1-b1f1-78edc7e274cc	2026-02-05	Warnings	Exact identifier application number: M020
Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30	AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE	Flageoli Limited	66f29201-6cbe-46d0-b54c-005a1ecefac4	2026-02-04	Warnings	Exact identifier application number: M020
Tanning Club Mineral Sunscreen SPF 30	ZINC OXIDE	Tanning Club LLC	d674ccbc-7bae-435c-a531-a79e569e69a9	2026-02-04	Warnings	Exact identifier application number: M020
Derma B Everyday Fit Sunscreen SPF 50	AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NeoPharm Co., Ltd.	ba38a43d-7a8a-4814-ba34-0e99124f5fca	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42	TITANIUM DIOXIDE AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	86630e82-f249-4866-82dd-3e21feb266c4	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	42adc51f-f500-485d-82a0-126672141262	2026-02-04	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
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61477-204-26	61477020426	177 mL in 1 BOTTLE, SPRAY (61477-204-26)	177 ml	2014-02-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALOE UP - ALOE ICE SPF 50 SPRAY (61477-204)	Aloe Care International, LLC	2026-01-28	HUMAN OTC DRUG LABEL	7