Tinted Sunscreen: Package Insert and Label Information

TINTED 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 & Administration

Dosage
(click image for full-size original)

Warnings Section

Warnings
(click image for full-size original)

Inactive Ingredients

Inactive Ingredient
(click image for full-size original)

Indications and Usage

Indications
(click image for full-size original)

Keep Out of Reach of Children

Keep out of reach
(click image for full-size original)

OTC — Purpose

Purpose
(click image for full-size original)

OTC — Active Ingredients

Active
(click image for full-size original)

Label Artwork

Label
(click image for full-size original)

Unit Carton

Unit Carton
(click image for full-size original)

TINTED SUNSCREEN
zinc oxide tinted sunscreen stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62932-213
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
COCONUT OIL
WHITE WAX
CANDELILLA WAX
CARNAUBA WAX
SUNFLOWER OIL
SHEA BUTTER
ALOE VERA LEAF
CALENDULA OFFICINALIS FLOWER
COCOA BUTTER
.BETA.-TOCOPHEROL
Product Characteristics
Color brown (Bare Neutral) , brown (Honey Beige) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62932-213-36 1 TUBE in 1 CARTON contains a TUBE
1 21 g in 1 TUBE This package is contained within the CARTON (62932-213-36)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 07/01/2019
Labeler — Private Label Select Ltd CO (005415463)

Revised: 01/2020 Private Label Select Ltd CO

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.