MEDICHOICE MOISTURIZING LIP BALM SPF15- avobenzone, octinoxate, octisalate, octocrylene cream

MediChoice Moisturizing Lip Balm SPF15 by

Drug Labeling and Warnings

MediChoice Moisturizing Lip Balm SPF15 by is a Otc medication manufactured, distributed, or labeled by O&M HALYARD, INC., Owens & Minor, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Avobenzone 3.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

• For external use only

Do not use

• on damaged or broken skin

Stop use and ask a doctor if

• rash occurs

When using this product

• keep out of eyes. Rinse with water to remove.

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 

Sun Protection MeasuresSpending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 

• limit time in the sun, especially from 10a.m.-2p.m.
• wear long sleeved shirts, pants hats, and sunglasses.

Inactive Ingredients:

Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

Other Information

Protect this product from excessive heat and direct sun.

Package Labeling:39892-0940-1

Package Labeling:39892-0940-2

Package Labeling:39892-0940-3

INGREDIENTS AND APPEARANCE

MEDICHOICE MOISTURIZING LIP BALM SPF15 
avobenzone, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39892-0940
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
CERESIN (UNII: Q1LS2UJO3A)
COCONUT OIL (UNII: Q9L0O73W7L)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39892-0940-1	4.2 g in 1 POUCH; Type 0: Not a Combination Product	12/22/2014
2	NDC: 39892-0940-2	100 in 1 BOX	12/22/2014
2		4.2 g in 1 CASE; Type 0: Not a Combination Product
3	NDC: 39892-0940-3	100 in 1 BOX	12/22/2014
3		4.2 g in 1 CASE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/22/2014

Labeler - O&M HALYARD, INC. (081057389)

Registrant - Owens & Minor, Inc (847412269)