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NDC 61477-0207-16 ALOE UP PRO 15 2; 5; 1.85 g/100mL; g/100mL; g/100mL Details
ALOE UP PRO 15 2; 5; 1.85 g/100mL; g/100mL; g/100mL
ALOE UP PRO 15 is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is AVOBENZONE; OCTISALATE; OCTOCRYLENE.
Product Information
| NDC | 61477-0207 |
|---|---|
| Product ID | 61477-207_dc93f993-675f-d8a9-e053-2a95a90a66f9 |
| 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 PRO 15 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | AVOBENZONE, OCTISALATE, OCTOCRYLENE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | TOPICAL |
| Active Ingredient Strength | 2; 5; 1.85 |
| Active Ingredient Units | g/100mL; g/100mL; g/100mL |
| Substance Name | AVOBENZONE; OCTISALATE; OCTOCRYLENE |
| 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 61477-0207-16 (61477020716)
| NDC Package Code | 61477-207-16 |
|---|---|
| Billing NDC | 61477020716 |
| Package | 177 mL in 1 BOTTLE, SPRAY (61477-207-16) |
| Marketing Start Date | 2014-02-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd Details
SPL UNCLASSIFIED SECTION
DIRECTIONS:
SPRAY LIBERALLY AND SPREAD EVENLY BY HAND 15 MINUTES BEFORE SUN EXPOSURE.
HOLD 4 TO 6 INCHES FROM THE SKIN TO APPLY.
DO NOT SPRAY DIRECTLY INTO FACE. SPRAY ON HANDS THEN APPLY TO FACE.
DO NOT APPLY IN WINDY CONDITIONS.
USE IN A WELL-VENTILATED AREA.
REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL DRYING, AT LEAST EVERY 2 HOURS.
SPL UNCLASSIFIED SECTION
WARNINGS:
FOR EXTERNAL USE ONLY. dO NOT USE ON DAMAGED OR BROKEN SKIN. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. KEEP AWAY FROM FACE TO AVOID BREATHING IT. CONTENTS UNDER PRESSURE- DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURES ABOUT 120 F. STOP USE AND ASK A DOCTOR IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. FLAMMABLE: DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| ALOE UP PRO 15
avobenzone, octisalate, octocrylene spray |
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| Labeler - Aloe Care International, LLC (938242187) |
| Registrant - Aloe Care International, LLC (938242187) |