DERMASIL SENSITIVE- dimethicone lotion 
Fantasia Beauty 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.

----------

Drug Facts

Active Ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

Warnings

  • 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

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 7.25 Tube Label

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 Tube Label

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 8 Bottle Label

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 9.25 Tube Label

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 Tube Label

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 10 Bottle Label

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 14.5 Bottle Label

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)

Principal Display Panel - Dermasil Sensitive 18.1 Bottle Label
DERMASIL SENSITIVE 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76184-0102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL OLEATE (UNII: 78K2L26L8N)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALLANTOIN (UNII: 344S277G0Z)  
ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
BORAGE OIL (UNII: F8XAG1755S)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ALMOND OIL (UNII: 66YXD4DKO9)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
VANILLA (UNII: Q74T35078H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76184-0102-1214 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
2NDC:76184-0102-2236 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
3NDC:76184-0102-3237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
4NDC:76184-0102-4274 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
5NDC:76184-0102-5296 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
6NDC:76184-0102-6296 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
7NDC:76184-0102-7429 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
8NDC:76184-0102-8535 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/30/2017
Labeler - Fantasia Beauty LLC (037273190)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Kingkey Fine Chemical Co., Ltd.545349263MANUFACTURE(76184-0102)

Revised: 8/2017
Document Id: b33c2aab-53d5-44d7-b2ec-3ab8d314a370
Set id: 87c01544-4ec8-4747-ab50-801805a2f451
Version: 1
Effective Time: 20170830
 
Fantasia Beauty LLC