CARMEX STRAWBERRY LIP BALM BROAD SPECTRUM SPF 15 SUNSCREEN - avobenzone, octisalate, homosalate and octocrylene salve 
Carma Laboratories, Inc.

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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CARMEX strawberry lip balm BROAD SPECTRUM SPF 15 SUNSCREEN

CARMEX strawberry lip balm BROAD SPECTRUM SPF 15 SUNSCREEN

Active Ingredients

Butyl Methoxydibenzoylmethane (Avobenzone) 2.5%

Ethylhexyl Salicylate (Octisalate) 3.0%

Homosalate 5.0%

Octocrylene 4.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally to lips 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

petrolatum, lanolin, flavor, beeswax, cetyl esters, theobroma cacao (cocoa) seed butter, mineral oil, camphor, menthol, phenol

Other Information

  • protect this product from excessive heat and direct sun

CARMEX strawberry lip balm BROAD SPECTRUM SPF 15 SUNSCREEN 10g (10210-0002-0)

StrawberryLipBalm1

StrawberryLipBalm2

CARMEX STRAWBERRY LIP BALM BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, octisalate, homosalate, octocrylene salve
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10210-0002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.5 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE3.0 g  in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE5.0 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE4.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
LANOLIN 
YELLOW WAX 
CETYL ESTERS WAX 
COCOA BUTTER 
MINERAL OIL 
CAMPHOR (NATURAL) 
MENTHOL 
PHENOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0002-010 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/26/2013
Labeler - Carma Laboratories, Inc. (006090153)
Registrant - Carma Laboratories, Inc. (006090153)
Establishment
NameAddressID/FEIBusiness Operations
Carma Laboratories, Inc.006090153manufacture(10210-0002)

Revised: 11/2013
Document Id: 0954c768-c2fc-49cc-85b0-8f6174da7a86
Set id: 5782639d-7f01-4eaf-ada9-d3e5dde10992
Version: 5
Effective Time: 20131120
 
Carma Laboratories, Inc.