CLARISONIC MIA 3 FACIAL SONIC CLEANSING BRUSH WITH DERMALOGICA TOTAL EYE CARE BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide lotion

Clarisonic Mia 3 Facial Sonic Cleansing Brush with Dermalogica total eye care broad spectrum SPF 15 sunscreen by

Drug Labeling and Warnings

Clarisonic Mia 3 Facial Sonic Cleansing Brush with Dermalogica total eye care broad spectrum SPF 15 sunscreen by is a Otc medication manufactured, distributed, or labeled by Pacific Bioscience Laboratories, Inc., PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Titanium dioxide 4.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

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

For sunscreen use:

● apply liberally and evenly 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending 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 10 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, C12-15 alkyl ethylhexanoate, butylene glycol, glycerin, silica, lactic acid, cetearyl alcohol, potassium cetyl phosphate, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, citrus aurantium amara (bitter orange) flower extract, spiraea ulmaria flower extract, centella asiatica extract, taurine, leucine, valine, tyrosine, arginine, lysine, sodium PCA, tocopheryl acetate, bisabolol, lauric acid, aluminum hydroxide, allantoin, ceteareth-20, xanthan gum, sodium hydroxide, propylene glycol, disodium EDTA, ethylhexylglycerin, phenoxyethanol, talc, iron oxides, mica

Questions or comments?

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLARISONIC MIA 3 FACIAL SONIC CLEANSING BRUSH WITH DERMALOGICA TOTAL EYE CARE BROAD SPECTRUM SPF 15 SUNSCREEN 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69481-637
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69481-637-01	1 in 1 CARTON	03/01/2015	03/01/2018
1		4 mL 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 not final	part352	03/01/2015

Labeler - Pacific Bioscience Laboratories, Inc. (024874849)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	manufacture(69481-637)