Drug Facts

Manufacturer
Pacific Bioscience Laboratories, Inc. | PakLab
Effective date
2018-12-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:41:25

Label at a glance#

ProductClarisonic Mia 3 Facial Sonic Cleansing Brush with Dermalogica total eye care broad spectrum SPF 15 sunscreen
Active ingredientTITANIUM DIOXIDE
Label structure13 sections

Indications and 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

Dosage and administration

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 includ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 4.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll free 1-800-831-5150

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69481-637-012020-10-29C16284748780-19d75b9d0-1531-f424-e053-dadaa90a57ceDrug Facts
69481-637-012020-01-31C16284748780-19d75b9d0-1531-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP5
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69481-63769481-637-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
db4b7470-d8e3-429c-818e-b381e50fbc40afba5630-725b-4765-bc63-6468be4d5e092020-10-29WarningsExact identifier
spl set id: afba5630-725b-4765-bc63-6468be4d5e09

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.