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

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. Skin Cancer/Skin Aging Alert:

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:10210-0023-1

Medicated SPF

Package Labeling: 10210-0023-4

Label

Package Labeling:10210-0023-5

Label02

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	35 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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
4	NDC:10210-0023-4	4 in 1 TRAY	09/26/2016
4		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
5	NDC:10210-0023-5	24 in 1 BOX	01/01/2023
5		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	09/26/2016

Labeler - Carma Laboratories, Inc. (006090153)

Carmex Classic Lip Balm Medicated SPF 15