SURFACE SUN SHEER TOUCH SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion 
Surface Products Corp

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 Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes 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:

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

Children under 6 months: ask a doctor.

Inactive Ingredients

Water, Behenyl Alcohol, BHT, Butyloctyl Salicylate, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, Hydrated Silica, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Sodium Polyacrylate, Styrene/Acrylates Copolymer, Tideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum.

Label

Surface Sun Sheer Touch SPF 30 LotionSurface Sun Sheer Touch SPF 30

SURFACE SUN SHEER TOUCH SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72344-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72344-008-06177 mL in 1 TUBE; Type 0: Not a Combination Product03/14/2018
2NDC:72344-008-0274 mL in 1 TUBE; Type 0: Not a Combination Product03/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/14/2018
Labeler - Surface Products Corp (010777036)
Registrant - CGI Packaging, LLC (080691099)
Establishment
NameAddressID/FEIBusiness Operations
CGI Packaging, LLC080691099manufacture(72344-008)

Revised: 5/2018
Document Id: 6d5d8bde-dd51-7919-e053-2991aa0a637b
Set id: 6d5d4380-05de-504d-e053-2991aa0aa3b7
Version: 2
Effective Time: 20180529
 
Surface Products Corp