Search by Drug Name or NDC
NDC 61477-0215-14 ALOE UP MEDICATED LIP ICE SUNSCREEN 6; 4; 7.5; 5 g/100g; g/100g; g/100g; g/100g Details
ALOE UP MEDICATED LIP ICE SUNSCREEN 6; 4; 7.5; 5 g/100g; g/100g; g/100g; g/100g
ALOE UP MEDICATED LIP ICE SUNSCREEN is a TOPICAL LIPSTICK in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is HOMOSALATE; MERADIMATE; OCTINOXATE; OXYBENZONE.
Product Information
NDC | 61477-0215 |
---|---|
Product ID | 61477-215_dc93f414-aa66-a9c8-e053-2a95a90a431e |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | ALOE UP MEDICATED LIP ICE SUNSCREEN |
Proprietary Name Suffix | SPF 30 |
Non-Proprietary Name | HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIPSTICK |
Route | TOPICAL |
Active Ingredient Strength | 6; 4; 7.5; 5 |
Active Ingredient Units | g/100g; g/100g; g/100g; g/100g |
Substance Name | HOMOSALATE; MERADIMATE; OCTINOXATE; OXYBENZONE |
Labeler Name | Aloe Care International, LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part352 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 61477-0215-14 (61477021514)
NDC Package Code | 61477-215-14 |
---|---|
Billing NDC | 61477021514 |
Package | 4.25 g in 1 TUBE (61477-215-14) |
Marketing Start Date | 2014-02-24 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 639e5509-f02c-499a-b455-bab656073d44 Details
DIRECTIONS:
SPL UNCLASSIFIED SECTION
WARNINGS:
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor if rash occurs
When using this product keep out of eyes. Rinse with water to remove.
INACTIVE INGREDIENTS
INGREDIENTS AND APPEARANCE
ALOE UP MEDICATED LIP ICE SUNSCREEN
SPF 30
homosalate, meradimate, octinoxate, oxybenzone lipstick |
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
Labeler - Aloe Care International, LLC (938242187) |
Registrant - Aloe Care International, LLC (938242187) |
Revised: 4/2022
Document Id: dc93f414-aa66-a9c8-e053-2a95a90a431e
Set id: 639e5509-f02c-499a-b455-bab656073d44
Version: 7
Effective Time: 20220413