AQUA BARRIER LOTUS ESSENCE MIST by NoTS Co.,Ltd / HANBUL COSMETICS CO.,LTD

Drug Details [pdf]

AQUA BARRIER LOTUS ESSENCE MIST- witch hazel spray
NoTS 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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ACTIVE INGREDIENT

Active Ingredient: Hamamelis Virginiana (Witch Hazel) Water 1.0%

INACTIVE INGREDIENT

Inactive Ingredients: SAUSSUREA INVOLUCRATA EXTRACT, WATER, BAMBUSA ARUNDINACEA STEM EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, LAMINARIA DIGITATA EXTRACT, GLYCINE, SERINE, GLUTAMIC ACID, ASPARTIC ACID, LEUCINE, ALANINE, LYSINE, ARGININE, TYROSINE, PHENYLALANINE, THREONINE, PROLINE, VALINE, ISOLEUCINE, HISTIDINE, METHIONINE, CYSTEINE, BUTYLENE GLYCOL, PHENOXYETHANOL, CAPRYLYL GLYCOL, OCTYLDODECANOL, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, PEG-60 HYDROGENATED CASTOR OIL, OCTYLDODECETH-16, OLEA EUROPAEA (OLIVE) FRUIT OIL, MACADAMIA INTEGRIFOLIA SEED OIL, PERSEA GRATISSIMA (AVOCADO) OIL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, ARGANIA SPINOSA KERNEL OIL, SODIUM CITRATE, SPIRULINA MAXIMA EXTRACT, PALMITOYL TRIPEPTIDE-5, HYDROLYZED ADANSONIA DIGITATA EXTRACT, BOSWELLIA SERRATA RESIN EXTRACT, ORCHID EXTRACT, DISODIUM EDTA, BETAINE, TREHALOSE, PANTHENOL, GALACTOMYCES FERMENT FILTRATE, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. Discontinue use if the following abnormal situations occur. If you continue to use, it may worsen symptoms, consult a dermatologist etc. A) If sings of redness, skin swelling, itchy spots, irritation or rash etc appear B) If the above signs appear in the applied area by direct rays of the sun 2. Do not use over wounds, rashes, inflammations or other troubled areas. 3. Do wash immediately in case of get in eye. 4. Do not use long term continuing in specification region. 5. Drop more than 20cm in human body as possible and that uses. 6. Notice when maintaining and handling A) You must close the cap after using B) Keep out of reach of children C) Do not keep in the place of high or low temperature and in direct sunlight D) Do not abandon in the fire E) DO not keep in hermetical place F) Do not keep in place of temperature of more than 40 degree.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: Keep distance about 20cm in your skin (Face and neck, etc... that need quick water) and sprays lightly. It is more effective if use after washing face, and available in make-up state.

DOSAGE & ADMINISTRATION

Dosage & administration: Apply adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AQUA BARRIER LOTUS ESSENCE MIST
witch hazel spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69716-140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	Witch Hazel	0.6 g in 60 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCINE (UNII: TE7660XO1C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69716-140-01	60 mL in 1 CARTON; Type 0: Not a Combination Product	01/02/2016	12/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/02/2016	12/01/2018

Labeler - NoTS Co.,Ltd (689004599)

Registrant - NoTS Co.,Ltd (689004599)

Name	Address	ID/FEI	Business Operations
Establishment
Nowcos.Co.,Ltd		689914984	manufacture(69716-140)

Revised: 12/2019

Document Id: 8f3ee804-a9e7-45f1-ba7c-5375bf404032

Set id: a3672079-4c15-4f19-bc3d-e5de68656d7e

Version: 3

Effective Time: 20191203