OTC Medication Information: Zinc Oxide Lip Balm Pina Colada

ZINC OXIDE LIP BALM PINA COLADA- 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.

OTC ACTIVE INGREDIENT

OTC Active Ingredients
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OTC PURPOSE SECTION

OTC Purpose
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OTC — KEEP OUT OF REACH OF CHILDREN

OTC Keep Out Of Reach Of Children
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ARTWORK

Artwork
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ZINC OXIDE LIP BALM PINA COLADA
zinc oxide lip balm pina colada stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62932-249
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
.BETA.-TOCOPHEROL
.GAMMA.-TOCOPHEROL
JOJOBA OIL
POLYHYDROXYSTEARIC ACID (2300 MW)
COCOA BUTTER
COCONUT OIL
SHEA BUTTER
RASPBERRY SEED OIL
SUNFLOWER OIL
POLYHYDROXYSTEARIC ACID STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL, D-
.DELTA.-TOCOPHEROL
TAMANU OIL
WHITE WAX
Product Characteristics
Color white Score
Shape Size
Flavor PINEAPPLE (Pina-colada) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62932-249-38 4.25 g in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/2020
Labeler — Private Label Select Ltd CO (005415463)

Revised: 12/2020 Private Label Select Ltd CO

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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