ALOE UP MEDICATED LIP BALM

Product NDC: 61477-224
11-digit product format: 614770224
Labeler code: 61477
Product ID: 61477-224_49a26858-d4e3-a984-e063-6294a90a5803
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: Aloe Care International, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-05-17
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 2; 7.5; 5; 2.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 4 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
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61477-224-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61477-224-11	`bd6a592717d7…`	`303034d00443…`

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 UP MEDICATED LIP BALM
Brand name suffix: SPF 30
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	2 g/100g
HOMOSALATE	7.5 g/100g
OCTISALATE	5 g/100g
OCTOCRYLENE	2.5 g/100g
OXYBENZONE	6 g/100g

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
859b6d3f-b1ca-4966-8f0c-f9afa0d5864c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-02-13	ALOE UP SPORT - MEDICATED LIP BALM SPF-30 (61477-224)
2024-01-30	ALOE UP SPORT - MEDICATED LIP BALM SPF-30 (61477-224)
2022-04-14	ALOE UP SPORT - MEDICATED LIP BALM SPF-30 (61477-224)
2022-01-28	ALOE UP SPORT - MEDICATED LIP BALM SPF-30 (61477-224)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61477-224-11	ALOE UP MEDICATED LIP BALMSPF 30	4.25 g in 1 TUBE	LIPSTICK	4.25		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61477-224	ALOE UP MEDICATED LIP BALM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]	7	Current NDC, Legacy NDC, 1 package rows	20240215_859b6d3f-b1ca-4966-8f0c-f9afa0d5864c.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 90 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	c656792a-e1ed-478d-b501-9bdc92d16eca	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTER	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	0a214b6b-69a7-4cb9-9095-6fcf2b6945de	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	fb6ac681-ff74-4420-a4f6-843d5f2b6d6b	2026-01-05	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	207e2035-5f31-4745-a801-b386b040b738	2026-01-05	Warnings	Exact identifier application number: M020
Hawaiian Blend Essential Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	47aa8605-e536-b998-e063-6394a90ad9f0	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	bf736c5b-fc33-4cd5-8d18-03929f739d76	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1	OCTINOXATE	SHISEIDO AMERICAS CORPORATION	8a9294c2-3933-4f9c-b7e6-1f446f441a16	2026-01-05	Warnings	Exact identifier application number: M020
Shiseido Future Solution LX Total Protective	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	6de17911-4bce-46c9-906b-07d899a36ceb	2026-01-05	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	c4028089-677f-4d51-9c8b-3892ff1649e0	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	8a0da327-a805-4ef9-b69a-14bf7278a81a	2026-01-05	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE CORRECTING VEIL n	ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	fd9b42e4-6f9d-45a9-bee3-ac1bc4b35252	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO THE MAKEUP FOUNDATION I20	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	3c024fe9-2983-4857-a55a-13406158e3a9	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3	2026-01-05	Warnings	Exact identifier application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY	ZINC OXIDE	Kao USA Inc.	26bcb9cd-bfb5-998c-e063-6394a90ab9d6	2026-01-05	Warnings	Exact identifier application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD	ZINC OXIDE	Kao USA Inc.	26cf1320-aae5-2ea0-e063-6394a90a3be2	2026-01-05	Warnings	Exact identifier application number: M020
OZE SUN BONDI	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	47b1aae6-0b86-7d48-e063-6294a90a9ece	2026-01-05	Warnings	Exact identifier application number: M020
Hybrid SPF SPF 30	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	Topiderm, Inc.	5c99f98c-025c-4886-824f-af968033baf4	2026-01-05	Warnings	Exact identifier application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus	TITANIUM DIOXIDE	HEY HONEY INC.	21187805-fae9-476c-81b0-27ffeb0b9911	2026-01-05	Warnings	Exact identifier application number: M020
VEAKSON BEEF TALLOW SUNSCREEN	ZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACID	Guangdong Aimu Biological Technology Co., Ltd	473c241a-1258-1680-e063-6394a90a7d98	2026-01-04	Warnings	Exact identifier application number: M020
HYDRATING SUNSCREEN	HYDRATING SUNSCREEN	Guangzhou Yapeng Refinement Chemical Co., Ltd.	19a3687b-32b0-7c83-e063-6294a90aaf81	2026-01-04	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
61477-224-11	61477022411	4.25 g in 1 TUBE (61477-224-11)	4.25 g	2019-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALOE UP SPORT - MEDICATED LIP BALM SPF-30 (61477-224)	Aloe Care International, LLC	2026-01-30	HUMAN OTC DRUG LABEL	8