Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Purpose

Sunscreen

Uses

helps protect against sunburn
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: • 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:

Orange Dream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 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 Daily Care Moisturizing Lip Balm Orange Dream SPF 15