AQUALANT- dimethicone oil 
Advanced Skin Technology, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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aqualant

Drug Facts

Active Ingredient

Dimethicone 24.92 percent

Purpose

Skin Protectant

Uses

Helps prevent and temporarily protects chafed, chapped or cracked skin.

Helps prevent and protect from the drying effects of wind and cold weather.

Warnings

For External Use Only

When using this product
Do not get into eyes.
Apply only when standing on a secure non-slippery surface.

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and reoccur within a few days.

Keep out of reach of children.

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

Directions

  • shake bottle vigorously before each use.
  • Apply liberally to wet skin after shower or bath and massage into skin.
  • Allow product to soak in and then lightly pat skin dry.

Inactive ingredients

Butyrospermum Parkii (Shea Butter) Fruit, Olea Europaea (Olive) Oil, Carthamus Tinctorius (Safflower) Oil, Vitis Vinifera (Grape) Seed Oil, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Tocopherol Acetate, Citrus Aurantifolia (Lime) Fruit Extract, Iodopropynyl Butyl Carbamate, Caprylic/Caprictriglyceride, Methyl Paraben, Butyl Paraben, Propylene Glycol, Sodium Ascorbate, Tocopherol, Retinol.

Questions

1-866-642-7546

www.AdvancedSkinTech.com

Representative Image of Label

aqualant (R)


MOISTURE SEALANT AND SKIN PROTECTANT

AFTER SHOWER TREATMENT



6 fl. oz. 177 ml



ADVANCED SKIN TECHNOLOGY



Manufactured for and

distributed by Advanced Skin

Technology, Inc.

Birmingham, AL 35203

Made in USA

www.aqualant.com

866-642-7546 Label

AQUALANT 
dimethicone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52205-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE249.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CITRUS AURANTIIFOLIA FLOWER (UNII: 43PX2HXI1S)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM ASCORBATE (UNII: S033EH8359)  
TOCOPHEROL (UNII: R0ZB2556P8)  
RETINOL (UNII: G2SH0XKK91)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52205-002-00177 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/201203/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/04/201203/05/2018
Labeler - Advanced Skin Technology, LLC (130977940)
Registrant - Advanced Skin Technology, LLC (130977940)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Skin Technology, LLC130977940manufacture(52205-002)

Revised: 3/2018
Document Id: 66af3eca-8bba-5780-e053-2a91aa0a7853
Set id: 556b3ff1-c59a-421e-8248-f6eb25708597
Version: 5
Effective Time: 20180305
 
Advanced Skin Technology, LLC