LIP BALM VANILLA SPF-15 - octinoxate and oxybenzone ointment 
Teton Outfitters LLC dba KLIM

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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Warnings:FOR EXTERNAL USE ONLY.  UV EXPOSURE FROM THE SUN INCREASES THE RISK OF SKIN CANCER, PREMATURE SKIN AGING, AND OTHER SKIN DAMAGE.  IT IS IMPORTANT TO DECREASE UV EXPOSURE BY LIMITING TIME IN THE SUN, WEARING PROTECTIVE CLOTHING AND USING A SUNSCREEN.

WHEN USING THIS PRODUCT KEEP OUT OF EYES.  RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF SKIN RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN.  IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

ACTIVE INGREDIENTS:  OCTINOXATE 7.5%, OXYBENZONE 3.0%

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: Ricinus Communis (Castor) Seed Oil; Hydrogenated Castor Oil; Ozokerite; Euphorbia Cerifera (Candelilla) Wax; Sorbitan Oleate; Flavor; Butyrospermum Parkii (Shea Butter); Prunus Amygdalus Dulcis(Sweet Almond) Oil; Santalum Album(Sandalwood) Wood Extract; Phellodendron Amurnse (Amur Corktree) Bark Extract; Hordeum Distichon (Barley) Extract; Glycine Soya (soybean) Oil; Prunus Armeniaca (Apricot) Kernel Oil; Tocopheryl Acetate; Phenoxyethanol; Sodium Saccharin; Menthol; Camphor


klimlbl

KLIM Technical Riding Gear   Paba-Free, Petrolatum-Free, UVA/UVB Lip Protection SPF 15 Lip Balm Vanilla Net Weight 0.17  0.17oz (4.8g) Made in the U.S.A.


LIP BALM VANILLA  SPF-15
octinoxate, oxybenzone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76269-187
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED 
HYDROGENATED CASTOR OIL 
CERESIN 
CANDELILLA WAX 
SORBITAN MONOOLEATE 
SHEA BUTTER 
ALMOND OIL 
SANDALWOOD 
PHELLODENDRON AMURENSE BARK 
BARLEY 
SOYBEAN OIL 
APRICOT KERNEL OIL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
PHENOXYETHANOL 
SACCHARIN SODIUM 
MENTHOL 
CAMPHOR (NATURAL) 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:76269-187-014.8 g in 1 CYLINDERNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2011

Labeler - Teton Outfitters LLC dba KLIM (820504432)

Revised: 07/2011 Teton Outfitters LLC dba KLIM