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DERMASIL SENSITIVE by Fantasia Beauty LLC

Medically reviewed on August 30, 2017.

Dosage form: lotion
Ingredients: DIMETHICONE 0.01g in 1mL
Labeler: Fantasia Beauty LLC
NDC Code: 76184-0102

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.

Drug Facts

Active Ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses
  • Temporarily protects and helps relieve chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.

Warnings
  • For external use only.
  • 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 Control Center right away.

Directions
  • Apply to Hands and Body every day.

INACTIVE INGREDIENTS:

WATER (AQUA), GLYCERIN, PETROLATUM, MINERAL OIL (PARAFFINUM LIQUIDUM), STEARIC ACID, GLYCOL STEARATE, GLYCERYL STEARATE, PEG-40 STEARATE, CETYL ALCOHOL, CETYL ACETATE, SODIUM HYDROXIDE, PHENOXYETHANOL, CARBOMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ALLANTOIN, ROSA DAMASCENA EXTRACT, DISODIUM EDTA, ACETYLATED LANOLIN ALCOHOL, METHYLISOTHIAZOLINONE, IODOPROPYNYL BUTYLCARBAMATE, MAGNESIUM ALUMINUM SILICATE, LECITHIN, BORAGO OFFICINALIS SEED OIL, CHOLESTEROL, ASCORBYL PALMITATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, ETHYLENE BRASSYLATE, SANTALUM ALBUM (SANDALWOOD) OIL, VANILLA PLANIFOLIA FRUIT EXTRACT.

Principal Display Panel - Dermasil Sensitive 7.25 Tube Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Sever Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Sensitive Skin Treatment

LOTION

7.25 FL. OZ. (214 ml)

Principal Display Panel - Dermasil Sensitive 8 Tube Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Sensitive Skin Treatment

LOTION

8 FL OZ (236 ml)

Principal Display Panel - Dermasil Sensitive 8 Bottle Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Sensitive Skin Treatment

LOTION

8 FL OZ (1/2 PINT, 237 ml)

Principal Display Panel - Dermasil Sensitive 9.25 Tube Label

VALUE
SIZE

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Sensitive Skin Treatment

LOTION

9.25 FL. OZ. (274 ml)

Principal Display Panel - Dermasil Sensitive 10 Tube Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Sensitive Skin Treatment

LOTION

10 FL. OZ. (296 ml)

Principal Display Panel - Dermasil Sensitive 10 Bottle Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Sensitive Skin Treatment

LOTION

10 FL. OZ. (3/5 PINT, 296 ml)

Principal Display Panel - Dermasil Sensitive 14.5 Bottle Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Sensitive Skin Treatment

LOTION

14.5 FL. OZ. (0.9 PINT, 429 ml)

Principal Display Panel - Dermasil Sensitive 18.1 Bottle Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Sensitive Skin Treatment

LOTION

18.1 FL. OZ. (1.1 PINT, 535 ml)

DERMASIL SENSITIVE 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76184-0102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PETROLATUM 
MINERAL OIL 
STEARIC ACID 
GLYCOL STEARATE 
GLYCERYL MONOSTEARATE 
PEG-40 STEARATE 
CETYL ALCOHOL 
CETYL OLEATE 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
CARBOMER HOMOPOLYMER TYPE C 
SUNFLOWER OIL 
ALLANTOIN 
ROSA X DAMASCENA FLOWER 
EDETATE DISODIUM 
ACETYLATED LANOLIN ALCOHOLS 
METHYLISOTHIAZOLINONE 
IODOPROPYNYL BUTYLCARBAMATE 
MAGNESIUM ALUMINUM SILICATE 
LECITHIN, SOYBEAN 
BORAGE OIL 
CHOLESTEROL 
ASCORBYL PALMITATE 
ALMOND OIL 
ETHYLENE BRASSYLATE 
SANDALWOOD OIL 
VANILLA 
Packaging
#Item CodePackage Description
1NDC:76184-0102-1214 mL in 1 TUBE
2NDC:76184-0102-2236 mL in 1 TUBE
3NDC:76184-0102-3237 mL in 1 BOTTLE
4NDC:76184-0102-4274 mL in 1 TUBE
5NDC:76184-0102-5296 mL in 1 TUBE
6NDC:76184-0102-6296 mL in 1 BOTTLE
7NDC:76184-0102-7429 mL in 1 BOTTLE
8NDC:76184-0102-8535 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/30/2017
Labeler - Fantasia Beauty LLC (037273190)
Establishment
NameAddressID/FEIOperations
Guangdong Kingkey Fine Chemical Co., Ltd.545349263MANUFACTURE(76184-0102)

 
Fantasia Beauty LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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