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 ingredientsPurpose
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

PRINCIPAL DISPLAY PANEL - 100 ml Container Carton
BALANCING EMULSION WITH GREEN TEA 
avobenzone, homosalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71220-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71220-007-041 in 1 CARTON05/13/201710/14/2019
1100 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/13/201710/14/2019
Labeler - Innisfree Corporation (557822425)
Establishment
NameAddressID/FEIBusiness Operations
COSVISION557789645manufacture(71220-007)

Revised: 10/2019
Document Id: 94f4be83-1adc-5e2a-e053-2995a90abca6
Set id: 65e91bd3-75ec-496b-bc7e-ef3af5a1003e
Version: 2
Effective Time: 20191015
 
Innisfree Corporation