PETROLEUM-FREE LIP BALM- octinoxate and oxybenzone lipstick 
Medline Industries, LP

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.

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092 Curad Petroleum-Free Lip Balm

Active ingredients

Octinoxate 2.0%

Oxybenzone 4.5%

Purpose

Sunscreen

Sunscreen

Use

Warnings

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 or irritation develops and lasts

Keep out of reach of children.

If swallowed, get medical help of contact a Poison Control Center right away.

Directions

Other Information

Inactive ingredients

beeswax, BHT, cocos nucifera (coconut) oil, flavor, helianthus annuus (sunflower) seed oil, lanolin, melaleuca alternifolia (tea tree) leaf oil, ricinus communis (castor) seed oil, tocopheryl acetate, zea mays (corn) oil.

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials

www.curad.com

1-800-633-5463

REF: CUR0415

V1 RD22OLB

Package Label

Label V1 RD22OLB

PETROLEUM-FREE LIP BALM 
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-092
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CASTOR OIL (UNII: D5340Y2I9G)  
LANOLIN (UNII: 7EV65EAW6H)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CORN OIL (UNII: 8470G57WFM)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-092-831 in 1 BOX04/01/2010
14.2 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02004/01/2010
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 026dec9e-b559-67a1-e063-6294a90ad50e
Set id: 6125d98a-6fc7-4f50-924e-3b1f7ee951f4
Version: 6
Effective Time: 20230808
 
Medline Industries, LP