Klim SPF15 Lip Balm - Vanilla

Lip Balm Vanilla by

Drug Labeling and Warnings

Lip Balm Vanilla by is a Otc medication manufactured, distributed, or labeled by Teton Outfitters LLC dba Klim Aggressive Sledwear. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIP BALM VANILLA SPF-15- octinoxate, oxybenzone ointment 
Teton Outfitters LLC dba Klim Aggressive Sledwear

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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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

LIP BALM VANILLA  SPF-15
octinoxate, oxybenzone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76269-187
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SHEA BUTTER (UNII: K49155WL9Y)
ALMOND OIL (UNII: 66YXD4DKO9)
SANDALWOOD (UNII: 3641YW25N2)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
BARLEY (UNII: 5PWM7YLI7R)
SOYBEAN OIL (UNII: 241ATL177A)
APRICOT SEED OIL (UNII: 54JB35T06A)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL (UNII: L7T10EIP3A)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76269-187-01	4.8 g in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2011	12/31/2019

Labeler - Teton Outfitters LLC dba Klim Aggressive Sledwear (820504432)

Revised: 12/2019

Document Id: af6f75a2-4d8c-4584-88e1-5fbb8d6d5bb1

34390-5

Set id: cebf4156-ea46-44b9-a687-8feb3055aa71

Version: 18

Effective Time: 20191215

 

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