ALOE UP PRO 15

Product NDC: 61477-207
11-digit product format: 614770207
Labeler code: 61477
Product ID: 61477-207_497ac89a-347e-07c8-e063-6394a90a4f51
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE, OCTISALATE, OCTOCRYLENE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Aloe Care International, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-02-24
Substance: AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength: 2; 5; 1.85 g/100mL; g/100mL; g/100mL
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	61477-207-16	`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	61477-207-16	`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 PRO 15
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	2 g/100mL
OCTISALATE	5 g/100mL
OCTOCRYLENE	1.85 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	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
5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-02-13	ALOE UP - PRO SPF 15 SPRAY (61477-207)
2023-07-28	ALOE UP - PRO SPF 15 SPRAY (61477-207)
2022-04-14	ALOE UP - PRO SPF 15 SPRAY (61477-207)
2022-01-28	ALOE UP - PRO SPF 15 SPRAY (61477-207)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61477-207-16	ALOE UP PRO 15	177 mL in 1 BOTTLE, SPRAY	SPRAY	177		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
DIBUTYL MALEATE	INACTIVE INGREDIENT	4X371TMK9K	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
DIETHYLHEXYL 2,6-NAPHTHALATE	INACTIVE INGREDIENT	I0DQJ7YGXM	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
ISOBORNYL METHACRYLATE	INACTIVE INGREDIENT	33GSY5DKCQ	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)	INACTIVE INGREDIENT	T9296U138P	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61477-207	ALOE UP PRO 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	9	Current NDC, Legacy NDC, 1 package rows	20240214_5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd.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 255 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Softlips Pearl	OCTINOXATE, OCTISALATE	The Mentholatum Company	43e175b4-7a48-431e-bf27-9ce7dee53f5e	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Oasis Watermelon Blackberry	DIMETHICONE, OXYBENZONE, OCTINOXATE	The Mentholatum Company	e1213808-4dad-4fd0-871a-04bba094a3cc	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Peppermint	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi	DIMETHICONE, OXYBENZONE, OCTINOXATE	The Mentholatum Company	7c8a4921-ae45-47fb-a64e-c72b1a386d0d	2024-12-17	Warnings	Exact identifier application number: M020
Mentholatum Medicated Lip Balm Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	6edb132d-bb67-4e6c-8e18-db0305073a71	2024-12-17	Warnings	Exact identifier application number: M020
Mentholatum Medicated Lip Balm Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1	2024-12-17	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Sport SPF 30	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	57c35631-42d3-4c6c-bcbb-e2de92b45b13	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	5f09503e-c455-4ac2-8d07-e8e66c2daa32	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	b5ca4bed-4f89-4020-a055-9d11f4cd5058	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	e5fffd20-1d22-485a-9311-4cb4f9264f6f	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	404990e4-9499-4186-b39d-afc31834d334	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	6028e210-a8a3-4d84-a462-16a414c31052	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Light	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e8	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30	AVOBENZONE/OCTISALATE/OCTOCRYLENE	Mary Kay Inc.	00f0f30d-236a-fd45-e063-6294a90a747d	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted Berry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	bab8447b-58b8-4160-a91e-05f9fd09ed1d	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE	MAKEUP ART COSMETICS	fb59afc1-1dc9-f783-e053-6394a90a196b	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30	ZINC OXIDE	Mary Kay Inc.	0e9b15e4-e59c-f266-e063-6394a90ab81c	2024-12-17	Warnings	Exact identifier application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	MAKEUP ART COSMETICS	e5fd3e40-de1d-4cdd-b725-4a517514ca35	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	2d034810-7210-4ad4-be23-ec2100f8c2f1	2024-12-17	Warnings	Exact identifier application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	acda1640-0d35-43dc-8734-d47b00cc85ed	2024-12-17	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
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
61477-207-16	61477020716	177 mL in 1 BOTTLE, SPRAY (61477-207-16)	177 ml	2014-02-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALOE UP - PRO SPF 15 SPRAY (61477-207)	Aloe Care International, LLC	2026-01-28	HUMAN OTC DRUG LABEL	10