MEDICATED LIP BALM- dimethicone, oxybenzone, and 2-ethylhexyl dimethyl paba cream

MEDICATED LIP BALM by

Drug Labeling and Warnings

MEDICATED LIP BALM by is a Otc medication manufactured, distributed, or labeled by Xtreme Tools International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Dimethicone 2.0%

Oxybenzone 2.5%

2-Ethylhexyl Dimethyl PABA 6.6%

Purpose

Dimethicone 2.0% - Lip protectant

Oxybenzone 2.5%- Sunscreen

2-Ethylhexyl Dimethyl PABA 6.6%- Sunscreen

Uses

• Temporarily protects and relieve chapped or cracked lips
• Helps prevent sunburn

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

Do not use on broken or damaged skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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
• use a water resistant sunscreen if swimming or sweating
• children under 6 years of age: Ask a doctor

Inactive ingredients

Prunus Arnygdalus Dulcis (Sweet Almond) Oil, Anthemis Nobilis Flower Extract, Hydrogenated Vegetable Oil, Beeswax, Shea Butter Ethyl Esters, Cocos Nucifera (Coconut) Oil, Argania Spinosa (Argan) Nut Oil, Tocopheryl Acetate, Organic flavors.

Other information

• protect this product from excessive heat and direct sun.

Questions or comments?

Call 1-305-622-7474 Monday through Friday 9:00 AM to 5:00 PM

PACKAGE LABEL

5 gram in Jar ; NDC: 74553-004-01

INGREDIENTS AND APPEARANCE

MEDICATED LIP BALM 
dimethicone, oxybenzone, and 2-ethylhexyl dimethyl paba cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74553-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 g  in 100 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	6.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74553-004-01	5 g in 1 JAR; Type 0: Not a Combination Product	10/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/14/2020

Labeler - Xtreme Tools International, Inc (125398904)

Registrant - Xtreme Tools International, Inc (125398904)

Establishment
Name	Address	ID/FEI	Business Operations
Xtreme Tools International, Inc		125398904	manufacture(74553-004)