CLARISONIC MIA 2 FACIAL SONIC BRUSH WITH FIRST AID BEAUTY ULTRA REPAIR SKIN PROTECTANT- colloidal oatmeal cream

Clarisonic Mia 2 Facial Sonic Brush with First Aid Beauty Ultra Repair Skin Protectant by

Drug Labeling and Warnings

Clarisonic Mia 2 Facial Sonic Brush with First Aid Beauty Ultra Repair Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Pacific Bioscience Laboratories, Inc., June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Colloidal oatmeal 0.5%

Purpose

Skin protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

• rashes
• eczema
• poison ivy, oak or sumac
• insect bites

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

apply as needed

Inactive ingredients

water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, dimethicone, butyrospermum parkii (shea) butter, squalane, phenoxyethanol, caprylyl glycol, allantoin, xanthan gum, sodium hydroxide, disodium EDTA, chrysanthemum parthenium (feverfew) extract, camellia sinensis (white tea) leaf extract, glycyrrhiza glabra (licorice) root extract, ceramide-3, eucalyptus globulus leaf extract

Questions or comments?

Call toll free 1-888-FAB-3063

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLARISONIC MIA 2 FACIAL SONIC BRUSH WITH FIRST AID BEAUTY ULTRA REPAIR SKIN PROTECTANT 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69481-539
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69481-539-01	1 in 1 CARTON	03/01/2015	03/01/2018
1		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2015

Labeler - Pacific Bioscience Laboratories, Inc. (024874849)

Establishment
Name	Address	ID/FEI	Business Operations
June Jacobs Labs, LLC		082439410	manufacture(69481-539)