Home NDC 61477-215 ALOE UP MEDICATED LIP ICE SUNSCREEN
Product NDC 61477-215
11-digit product format 614770215
Labeler code 61477
Product ID 61477-215_dc93f414-aa66-a9c8-e053-2a95a90a431e
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, MERADIMATE, 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 HOMOSALATE; MERADIMATE; OCTINOXATE; OXYBENZONE
Active strength 6 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 61477-215-14 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 61477-215-14 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61477-215-14 ALOE UP MEDICATED LIP ICE SUNSCREENSPF 30 4.25 g in 1 TUBE LIPSTICK 4.25 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HOMOSALATE ACTIVE INGREDIENT V06SV4M95S ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 MERADIMATE ACTIVE INGREDIENT J9QGD60OUZ ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 HOMOSALATE ACTIVE MOIETY V06SV4M95S ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 MERADIMATE ACTIVE MOIETY J9QGD60OUZ ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 CAMPHOR (SYNTHETIC) INACTIVE INGREDIENT 5TJD82A1ET ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 CERESIN INACTIVE INGREDIENT Q1LS2UJO3A ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 ALOE UP MEDICATED LIP BALM SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61477-215 ALOE UP MEDICATED LIP ICE SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 8 Legacy NDC, 1 package rows 20240214_639e5509-f02c-499a-b455-bab656073d44.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61477-215-14 61477021514 4.25 g in 1 TUBE (61477-215-14) 4.25 g 2014-02-24 0000-00-00 No No Current