Lip Balm Vanilla SPF-15

Dosage form: ointment
Ingredients: OCTINOXATE 7.5g in 100g, OXYBENZONE 3.0g in 100g
Labeler: Teton Outfitters LLC dba Klim Aggressive Sledwear
NDC Code: 76269-187

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.

Klim SPF15 Lip Balm - Vanilla

Active Ingredients

Octinoxate   7.5%,

Oxybenzone 3.0%

Purpsoe

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to 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 or 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 of age: ask a doctor

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


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 SEED OIL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
PHENOXYETHANOL 
SACCHARIN SODIUM 
MENTHOL 
CAMPHOR (NATURAL) 
Packaging
#Item CodePackage Description
1NDC:76269-187-014.8 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2011
Labeler - Teton Outfitters LLC dba Klim Aggressive Sledwear (820504432)

Revised: 06/2014
 
Teton Outfitters LLC dba Klim Aggressive Sledwear

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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