ALOE UP DARK TANNING OIL SPF 4

Product NDC
61477-216
Requested package NDC
61477-216-26
11-digit product format
614770216
Labeler code
61477
Product ID
61477-216_dc94971d-133d-9018-e053-2a95a90ad2b2
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Aloe Care International, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-02-24
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE
Active strength
2 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61477-21661477-216-26IInactivated by FDA2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61477-21661477-216-26IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61477-21661477-216-26IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-216-26ALOE UP DARK TANNING OIL SPF 4CONTINUOUS SUNSCREEN177 mL in 1 BOTTLE, SPRAYSPRAY1779

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61477-216ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN (OCTINOXATE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC]9Legacy NDC, 1 package rows20240214_5e12224b-93d9-4175-a395-60aa4ff11e93.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61477-216-2661477021626177 mL in 1 BOTTLE, SPRAY (61477-216-26) 177 ml2014-02-240000-00-00NoNoCurrent