SUNSCREEN: Package Insert and Label Information

SUNSCREEN- zinc oxide stick
Private Label Select Ltd CO

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Dosage and Administration

Dosage and administration
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Warnings Section

Warnings Section
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Inactive Ingredients

Inactive Ingredients
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Indications and Usage

Indications and Usage
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OTC Keep put of reach of children

OTC Keep put of reach of children
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OTC Active Ingredient

OTC Active Ingredient
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OTC Purpose

OTC Purpose
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Label/Artwork

Label
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Display Case

Display Carton
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SUNSCREEN
zinc oxide sunscreen stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62932-217
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 10.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
SHEA BUTTER
TAMANU OIL
COCOA BUTTER
COCONUT OIL
JOJOBA OIL
WHITE WAX
SUNFLOWER OIL
POLYHYDROXYSTEARIC ACID (2300 MW)
TOCOPHEROL
RASPBERRY SEED OIL
Product Characteristics
Color white Score
Shape Size
Flavor COCONUT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62932-217-38 12 CONTAINER in 1 CARTON contains a CONTAINER
1 4.25 g in 1 CONTAINER This package is contained within the CARTON (62932-217-38)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/01/2020
Labeler — Private Label Select Ltd CO (005415463)

Revised: 04/2020 Private Label Select Ltd CO

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