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

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
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE2.75 g/100mL
OXYBENZONE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM, 95OOS7VE0Y

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61477-204-262024-02-13C16284748780-10191ceaa-6899-198a-e063-dbdaa90aec3eALOE UP - ALOE ICE SPF 50 SPRAY (61477-204)
61477-204-262023-07-28C16284748780-10191ceaa-6899-198a-e063-dbdaa90aec3eALOE UP - ALOE ICE SPF 50 SPRAY (61477-204)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-204-26ALOE ICESPF 50177 mL in 1 BOTTLE, SPRAYSPRAY1777

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61477-204ALOE ICE SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]6Current NDC, Legacy NDC, 1 package rows20240214_e4b861d2-3680-4ed7-8650-d1d839da5ab2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61477-204-2661477020426177 mL in 1 BOTTLE, SPRAY (61477-204-26) 177 ml2014-02-240000-00-00NoNoCurrent