ALOE UP NATURAL LIP ICE SUNSCREEN

Product NDC
61477-214
11-digit product format
614770214
Labeler code
61477
Product ID
61477-214_dc93f993-6754-d8a9-e053-2a95a90a66f9
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE
Dosage form
LIPSTICK
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/100g; g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61477-214IInactivated by FDA2026-10-05
excluded packagepackage61477-21461477-214-14IInactivated 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 · 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 packagepackage61477-214-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61477-214-14bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61477-214-142022-04-16C16284748780-1d6a99b39-d1d3-a426-e053-dadaa90af4c2ALOE UP - NATURAL LIP ICE SPF 15 (61477-214)
61477-214-142022-01-28C16284748780-1d6a99b39-d1d3-a426-e053-dadaa90af4c2ALOE UP - NATURAL LIP ICE SPF 15 (61477-214)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-214-14ALOE UP NATURAL LIP ICE SUNSCREEN4.25 g in 1 TUBELIPSTICK4.257

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC1ALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918CALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
LANOLININACTIVE INGREDIENT7EV65EAW6HALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
MANGIFERA INDICA SEED BUTTERINACTIVE INGREDIENT4OXD9M35X2ALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8ALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61477-214ALOE UP NATURAL LIP ICE SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC]7Legacy NDC, 1 package rows20240214_3bb01ac0-ccba-46b3-8850-b04d0c651300.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61477-214-14614770214144.25 g in 1 TUBE (61477-214-14) 4.25 g2014-02-240000-00-00NoNoCurrent