CARMEX DAILY CARE MOISTURIZING LIP BALM ORANGE DREAM SPF 15- octinoxate, oxybenzone salve

Carmex Daily Care Moisturizing Lip Balm Orange Dream SPF 15 by

Drug Labeling and Warnings

Carmex Daily Care Moisturizing Lip Balm Orange Dream 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%

Purpose

Sunscreen

Uses

• helps protect against sunburn
• 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:  after 80 minutes of swimming or sweating  immediately after towel drying  at least every 2 hours
• children under 2 years of age: 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

   petrolatum, lanolin, euphorbia cerifera cera, isopropyl palmitate, ozokerite, flavor, beeswax, cetly esters, paraffin, theobroma cacao seed butter, limnanthes alba seed oil, stevia rebaudiana extract

Package Labeling:

INGREDIENTS AND APPEARANCE

CARMEX DAILY CARE MOISTURIZING LIP BALM ORANGE DREAM SPF 15 
octinoxate, oxybenzone salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0013
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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CERESIN (UNII: Q1LS2UJO3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0013-1	1 in 1 CARTON	09/26/2016
1		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)