FDA.reportPublic FDA data

ALOE UP PRO 50

Product NDC
61477-211
11-digit product format
614770211
Labeler code
61477
Product ID
61477-211_497ac89a-347f-07c8-e063-6394a90a4f51
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

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61477-211-2686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61477-211-26bd6a592717d7…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 50
Brand name suffix
CONTINUOUS SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE2.75 g/100mL
OXYBENZONE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc33d9e8-3463-485d-a1ee-6319ed91454cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-02-13ALOE UP - PRO SPF 50 SPRAY (61477-211)
2023-07-28ALOE UP - PRO SPF 50 SPRAY (61477-211)
2022-04-14ALOE UP - PRO SPF 50 SPRAY (61477-211)
2022-01-28ALOE UP - PRO SPF 50 SPRAY (61477-211)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-211-26ALOE UP PRO 50CONTINUOUS SUNSCREEN177 mL in 1 CANSPRAY1776

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
HOMOSALATEACTIVE MOIETYV06SV4M95SALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
OCTISALATEACTIVE MOIETY4X49Y0596WALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
DIBUTYL MALEATEINACTIVE INGREDIENT4X371TMK9KALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
ISOBORNYL METHACRYLATEINACTIVE INGREDIENT33GSY5DKCQALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138PALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61477-211ALOE UP PRO 50 CONTINUOUS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]5Current NDC, Legacy NDC, 1 package rows20240214_dc33d9e8-3463-485d-a1ee-6319ed91454c.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 247 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION06ab109e-abcf-0861-e063-6394a90a93752024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d3379ba-465d-a889-e063-6394a90aaf232024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d339273-6d82-0979-e063-6394a90a3de72024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0cc97b34-e9e6-ef6a-e063-6394a90aee892024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0cc9760b-b88b-f291-e063-6294a90a242f2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d338ec2-dca0-e032-e063-6394a90a69aa2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0752d79d-5d82-0367-e063-6394a90a4f1c2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d33888d-20b3-f912-e063-6394a90a25dc2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d3379ba-465c-a889-e063-6394a90aaf232024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b25290-33a0-bafd-e063-6394a90a7a942024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0751b356-607f-f3cb-e063-6294a90a40922024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b14a17-cace-1b3e-e063-6394a90afe5d2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION07530636-cd21-3022-e063-6394a90a89d62024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0752753e-cac9-9166-e063-6394a90a4d8d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06ad3c09-9f1b-b25c-e063-6294a90aebe12024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c57ff5-7013-d35f-e063-6394a90a6ee22024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b29-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44de-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44ef-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b25290-33a3-bafd-e063-6394a90a7a942024-12-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61477-211-2661477021126177 mL in 1 CAN (61477-211-26) 177 ml2014-02-240000-00-00NoNoCurrent