DERMASIL SENSITIVE- dimethicone lotion
Fantasia Beauty LLC

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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 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 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)

Principal Display Panel - Dermasil Sensitive 18.1 Bottle Label

DERMASIL SENSITIVE
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76184-0102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.01 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76184-0102-1	214 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017	12/31/2023
2	NDC:76184-0102-2	236 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017	12/31/2023
3	NDC:76184-0102-3	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017	12/31/2023
4	NDC:76184-0102-4	274 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017	12/31/2023
5	NDC:76184-0102-5	296 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017	12/31/2023
6	NDC:76184-0102-6	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017	12/31/2023
7	NDC:76184-0102-7	429 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017	12/31/2023
8	NDC:76184-0102-8	535 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	08/30/2017	12/31/2023

Labeler - Fantasia Beauty LLC (037273190)

Name	Address	ID/FEI	Business Operations
Establishment
Guangdong Kingkey Fine Chemical Co., Ltd.		545349263	MANUFACTURE(76184-0102)

Revised: 10/2023

Document Id: 504b3e1f-c08b-4fd5-8ff3-5ae2d35ca487

Set id: 87c01544-4ec8-4747-ab50-801805a2f451

Version: 2

Effective Time: 20231005

Fantasia Beauty LLC