balancing emulsion with green tea

Drug Labeling and Warnings

Drug Details [pdf]

BALANCING EMULSION WITH GREEN TEA- avobenzone, homosalate, and octocrylene lotion 
Innisfree Corporation

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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balancing emulsion with green tea

Drug Facts

Active ingredients	Purpose
Avobenzone (2.5%)	Sunscreen
Homosalate (3%)	Sunscreen
Octocrylene (8%)	Sunscreen

Use

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

• For external use only

• Do not use on damaged or broken skin

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs

• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor

Inactive ingredients

water, propanediol, methyl trimethicone, alcohol, c14-22 alcohols, silica, glyceryl stearate, glyceryl stearate citrate, vp/eicosene copolymer, fragrance, c12-20 alkyl glucoside, carbomer, glyceryl caprylate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, tromethamine, glycerin, disodium edta, ethylhexylglycerin, xanthan gum, glycine soja (soybean) oil, camellia sinensis leaf extract, camellia japonica leaf extract, citrus unshiu peel extract, opuntia coccinellifera fruit extract, orchid extract, althaea officinalis root extract, citrus aurantium bergamia (bergamot) fruit extract, citrus aurantium dulcis (orange) fruit extract, citrus paradisi (grapefruit) fruit extract, citrus tangerina (tangerine) extract, lactic acid, ascorbic acid, citric acid

Other information

• protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 100 ml Container Carton

innisfree

balancing
emulsion

with green tea

broad spectrum SPF 13

3.38 FL.OZ./100ml

BALANCING EMULSION WITH GREEN TEA 
avobenzone, homosalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71220-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ALCOHOL (UNII: 3K9958V90M)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
TROMETHAMINE (UNII: 023C2WHX2V)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
SOYBEAN OIL (UNII: 241ATL177A)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71220-007-04	1 in 1 CARTON	05/13/2017	10/14/2019
1		100 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/13/2017	10/14/2019

Labeler - Innisfree Corporation (557822425)

Establishment
Name	Address	ID/FEI	Business Operations
COSVISION		557789645	manufacture(71220-007)

Revised: 10/2019

Document Id: 94f4be83-1adc-5e2a-e053-2995a90abca6

34390-5

Set id: 65e91bd3-75ec-496b-bc7e-ef3af5a1003e

Version: 2

Effective Time: 20191015