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Petroleum-Free Lip Balm

Dosage form: lipstick
Ingredients: OCTINOXATE 2g in 100g, OXYBENZONE 4.5g in 100g
Labeler: Medline Industries, Inc.
NDC Code: 53329-092

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.

Drug Facts

Active ingredient

Octinoxate (2.0%), Oxybenzone (4.5%)

Purpose

Sunscreen

Uses
  • Helps prevent sunburn

Warnings
  • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has ben shown only to help prevent sunburn, not skin cancer or early skin aging.
  • 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 swallowed, get medical help of contact a Poison Control Center right away.

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

Inactive ingredients

Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos-Nucifera (Coconut) Oil, Flavor, Zea Mays (Corn) Oil (and) BHT, Tocopheryl Acetate, Melaleuca Alterifolia (Tea Tree) Leaf Oil.

Other Information
  • protect this product from excessive heat and direct sun
  • to report a suspected adverse reaction, contact Curad.

Questions or Comments?

Call toll free 1-800-633-5463

www.curadusa.com

Package/Label Principal Display Panel

NDC: 53329-092-83

Curad®

WE HELP HEAL

SPF 15

Sunscreen

CUR04015

Petroleum-Free Lip Balm

Moisturizing • Natural Beeswax

Mint Flavor

NET WT. .15 oz. (4.2g)

PETROLEUM-FREE LIP BALM 
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-092
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE4.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
SUNFLOWER OIL 
CASTOR OIL 
LANOLIN 
COCONUT OIL 
CORN OIL 
BUTYLATED HYDROXYTOLUENE 
ALPHA-TOCOPHEROL ACETATE 
TEA TREE OIL 
Packaging
#Item CodePackage Description
1NDC:53329-092-831 CONTAINER in 1 BOX
14.2 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2010
Labeler - Medline Industries, Inc. (025460908)

Revised: 05/2016
 
Medline Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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