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NDC 61477-0213-14 ALOE UP SUNSCREEN 3; 5; 6; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Details
ALOE UP SUNSCREEN 3; 5; 6; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
ALOE UP SUNSCREEN is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE.
Product Information
| NDC | 61477-0213 |
|---|---|
| Product ID | 61477-213_dc949d17-dad2-8ac7-e053-2995a90ad4c5 |
| 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 SUNSCREEN |
| Proprietary Name Suffix | SPF 50 |
| Non-Proprietary Name | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 3; 5; 6; 5; 10 |
| Active Ingredient Units | g/100mL; g/100mL; g/100mL; g/100mL; g/100mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTINOXATE; 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 61477-0213-14 (61477021314)
| NDC Package Code | 61477-213-14 |
|---|---|
| Billing NDC | 61477021314 |
| Package | 118 mL in 1 TUBE (61477-213-14) |
| Marketing Start Date | 2014-02-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 00e86762-db83-4c3a-9ce7-7b3f2ab0b3bd Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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. 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.
SPL UNCLASSIFIED SECTION
Other Ingredients:
ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, ALUMINUM STARCH OCTENYLSUCCINATE, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS LEAF EXTRACT, CARBOMER, IODOPROPYNYL BUTYLCARBAMATE, ISODECYL NEOPENTANOATE, METHYLISOTHIAZOLINONE, PHENOXYETHANOL, POLYETHYLENE, POLYSORBATE 20, PROPANEDIOL, SORBITOL, THEOBROMA CACAO (COCOA) SEED BUTTER, TOCOPHERYL ACETATE, TRIETHANOLAMINE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, WATER
INGREDIENTS AND APPEARANCE
| ALOE UP SUNSCREEN
SPF 50
avobenzone, homosalate, octisalate, octocrylene, octinoxate lotion |
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| Labeler - Aloe Care International, LLC (938242187) |
| Registrant - Aloe Care International, LLC (938242187) |