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Drug Facts

Manufacturer
Pacific Bioscience Laboratories, Inc. | June Jacobs Labs, LLC
Effective date
2018-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:41:22

Label at a glance#

ProductClarisonic Mia 2 Facial Sonic Brush with First Aid Beauty Ultra Repair Skin Protectant
Active ingredientOATMEAL
Label structure11 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak or sumac insect bites

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal oatmeal 0.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll free 1-888-FAB-3063

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69481-539-012020-10-29C16284748780-19d75b9d0-6ca6-f424-e053-dadaa90a57ceDrug Facts
69481-539-012020-01-31C16284748780-19d75b9d0-6ca6-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663Y1
OATMEALACTIVE MOIETY8PI54V663Y1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69481-53969481-539-01

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
OATMEAL8PI54V663YACTIB
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
2c1ca095-3781-49a4-82fd-4b6a2190148092641ca4-9360-4873-bada-5878d1f4d8e82020-10-29WarningsExact identifier
spl set id: 92641ca4-9360-4873-bada-5878d1f4d8e8

Reported adverse events (FAERS/openFDA)#

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