CARMEX CLASSIC LIP BALM MEDICATED SPF 15- octinoxate, oxybenzone, petrolatum salve

Carmex Classic Lip Balm Medicated SPF 15 by

Drug Labeling and Warnings

Carmex Classic Lip Balm Medicated SPF 15 by is a Otc medication manufactured, distributed, or labeled by Carma Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

White Petrolatum 35.00%

Purpose

Sunscreen

Lip Protectant

Uses

• helps protect against sunburn and chapped lips
• higher SPF gives more sunburn protection

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 help 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
• reapply: at least every 2 hours
• children under 2 years: ask a doctor

Other Information

• this is a personal care item, and should be used by one individual only
• protect this product from excessive heat and direct sun
• do not use if safety seal is broken prior to purchase

Inactive Ingredients

lanolin, theobroma cacao seed butter, euphorbia cerifera wax, beeswax, cetyl esters, ozokerite, paraffin, limnanthes alba seed oil, camphor, menthol, salicylic acid, phenol, flavor, vanillin

Package Labeling:

INGREDIENTS AND APPEARANCE

CARMEX CLASSIC LIP BALM MEDICATED SPF 15 
octinoxate, oxybenzone, petrolatum salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0023
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	4 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	35 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MENTHOL (UNII: L7T10EIP3A)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PHENOL (UNII: 339NCG44TV)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0023-1	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product	09/26/2016
2	NDC: 10210-0023-2	3 in 1 PACKAGE	09/26/2016
2		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
3	NDC: 10210-0023-3	1 in 1 CARTON	09/26/2016
3		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/26/2016

Labeler - Carma Laboratories, Inc. (006090153)