DERMASIL DRYSKIN- 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.

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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, DISODIUM EDTA, ACETYLATED LANOLIN ALCOHOL, GERANIUM MACULATUM OIL, 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, ROSA DAMASCENA EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT.

Principal Display Panel - Dermasil Dryskin 7.25 Tube Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Sever Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Dry Skin Treatment

ORIGINAL LOTION

7.25 FL. OZ. (214 ml)

Principal Display Panel - Dermasil Dryskin 7.25 Tube Label

Principal Display Panel - Dermasil Original 8 Tube Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Dry Skin Treatment

ORIGINAL LOTION

8 FL OZ (236 ml)

Principal Display Panel - Dermasil Original 8 Tube Label

Principal Display Panel - Dermasil Original 8 Bottle Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Dry Skin Treatment

ORIGINAL LOTION

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

Principal Display Panel - Dermasil Original 8 Bottle Label

Principal Display Panel - Dermasil Dry Skin 9.25 Tube Label

VALUE
SIZE

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Dry Skin Treatment

ORIGINAL LOTION

9.25 FL. OZ. (274 ml)

Principal Display Panel - Dermasil Dry Skin 9.25 Tube Label

Principal Display Panel - Dermasil Dryskin 10 Tube Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Dry Skin Treatment

ORIGINAL LOTION

10 FL. OZ. (296 ml)

Principal Display Panel - Dermasil Dryskin 10 Tube Label

Principal Display Panel - Dermasil Dryskin 10 Bottle Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Dry Skin Treatment

ORIGINAL LOTION

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

Principal Display Panel - Dermasil Dryskin 10 Bottle Label

Principal Display Panel - Dermasil Dryskin 14.5 Bottle Label

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Dry Skin Treatment

ORIGINAL LOTION

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

Principal Display Panel - Dermasil Dryskin 14.5 Bottle Label

Principal Display Panel - Dermasil Dryskin 18.1 Bottle Label

25 %
MORE

Dermasil®

LABS

Pharmaceutical Research

Controls Even Severe Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Dry Skin Treatment

ORIGINAL LOTION

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

Principal Display Panel - Dermasil Dryskin 18.1 Bottle Label
DERMASIL DRYSKIN 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76184-0101
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)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)  
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)  
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
VANILLA (UNII: Q74T35078H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76184-0101-1214 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
2NDC:76184-0101-2236 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
3NDC:76184-0101-3237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
4NDC:76184-0101-4274 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
5NDC:76184-0101-5296 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
6NDC:76184-0101-6296 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
7NDC:76184-0101-7429 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
8NDC:76184-0101-8535 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(76184-0101)

Revised: 8/2017
Document Id: 2272a180-8aa3-4b29-b9c2-4529749b9041
Set id: 8a49f4be-8a73-41ca-86f4-11a707b2987a
Version: 1
Effective Time: 20170830
 
Fantasia Beauty LLC