Sallys Box Secret Garden Olive Oil Ampoule Mask by Imine Co., Ltd 59401-011_Deactivation

Sallys Box Secret Garden Olive Oil Ampoule Mask by

Drug Labeling and Warnings

Sallys Box Secret Garden Olive Oil Ampoule Mask by is a Otc medication manufactured, distributed, or labeled by Imine Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALLYS BOX SECRET GARDEN OLIVE OIL AMPOULE MASK- dimethicone cream 
Imine Co., Ltd

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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59401-011_Deactivation

Dimethicone (2.375%)

Moisturizing + Soothing + Lifting

Use with caution if you are highly sensitive to any bandages or wet compresses.

Apply one mask sheet at a time.

Skin Protectant

1. After cleansing your face, apply step 1-ampoule serum to face. 2 Before step 1- ampoule serum is completely absorbed, take the step2-mask sheet out from the package and attach it evenly over your face avoiding the eye and mouth area. 3. Remove it after 10-20 minutes. Using your fingers, gently pat any remaining essence into the skin until thoroughly absorbed.

Keep out of reach of children.

If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above.

Avoid contact with eyes. In case of contact with eyes, rinse immediately with water.

Do not use the product on an open skin wound or on areas of eczema or infection.

<Step 1> Water, Butylene Glycol, Glycerin , Cyclopentasiloxane , Cetearyl Alcohol, Cetyl Ethylhexanoate , Citrus Paradisi (Grapefruit) Fruit Extract, Stearic Acid, Cyclohexasiloxane, Hydrogenated Vegetable Oil , Olea Europaea (Olive) Leaf Extract, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Glucoside, Dimethiconol , Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Polyacrylate, Hydrogenated Polydecene, Ethylhexylglycerin, Trideceth-6, Portulaca Grandiflora Extract , Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Extract , Chamomilla Recutita (Matricaria) Flower Extract , Camellia Sinensis Leaf Extract , Paeonia Albiflora Root Extract , Jasminum Officinale (Jasmine) Extract , Mentha Viridis (Spearmint) Extract , Scutellaria Baicalensis Root Extract, Olea Europaea (Olive) Fruit Oil , Sodium Hyaluronate, Disodium EDTA, Phenoxyethanol, Fragrance
<Step 2> Water, Butylene Glycol, Glycerin, PEG/PPG-17/6 Copolymer, Alcohol, PEG-75, Citrus Paradisi (Grapefruit) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Panthenol, PEG-60 Hydrogenated Castor Oil, Carbomer, Potasium Hydroxide, Ethylhexylglycerin, Sodium Polyacrylate, Allantoin, Portulaca Grandiflora Extract , Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Extract , Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis Leaf Extract , Paeonia Albiflora Root Extract , Jasminum Officinale (Jasmine) Extract , Mentha Viridis (Spearmint) Extract , Scutellaria Baicalensis Root Extract, Olea Europaea (Olive) Fruit Oil , Sodium Hyaluronate, Disodium EDTA, Phenoxyethanol, Fragrance

SALLYS BOX SECRET GARDEN OLIVE OIL AMPOULE MASK 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59401-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.4988 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
GRAPEFRUIT (UNII: O82C39RR8C)
STEARIC ACID (UNII: 4ELV7Z65AP)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PORTULACA GRANDIFLORA SEED (UNII: 73NV03RHQT)
ROSEMARY (UNII: IJ67X351P9)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
CHAMOMILE (UNII: FGL3685T2X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
MENTHA SPICATA (UNII: O2H83I4PUN)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59401-011-01	21 mL in 1 POUCH; Type 0: Not a Combination Product	11/19/2014	12/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/19/2014	12/27/2019

Labeler - Imine Co., Ltd (557816813)

Registrant - Imine Co., Ltd (557816813)

Establishment
Name	Address	ID/FEI	Business Operations
i Mine Co.,Ltd.		557816813	manufacture(59401-011)

Revised: 12/2019

Document Id: 9ab4a961-c449-cc92-e053-2a95a90a56bf

34390-5

Set id: 11cb11b3-ee6f-4e07-97e3-4baebae21194

Version: 3

Effective Time: 20191227