SURFACE SHEER TOUCH SPF 50 WITH FRAGRANCE- avobenzone, homosalate, octisalate, octocrylene lotion

Surface Sheer Touch SPF 50 with Fragrance by

Drug Labeling and Warnings

Surface Sheer Touch SPF 50 with Fragrance by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

WARNINGS

WARNINGS

For external use only.

Highly Flammable: Do not apply or use product near heat, flame, or while smoking.

WHEN USING

When using this product:

keep out of eyes. Rinse with water to remove.

Keep away from face to avoid breathing it.

Do not puncture or incinerate, Contents under pressure

Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

Behenyl Alcohol

BHT

Butyloctyl Salocylate

Caprylyl Methicone

Dimethicone

Dimethyl Capramide

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Fragrance

Glyceryl Stearate

Hydrated Silicia

PEG-100 Stearate

Phenoxyethanol

Polyester-8

Sodium Polyacrylate

Styrene/ Acrylate Copolymer

Trideceth-6

Trimethylsiloxysilicate

VP/Hexadecene Copolyer

Water

Xanthan Gum

STOP USE

Stop use and ask a doctor if rash occurs.

PURPOSE

Avobenzone 3.0% ..............................Sunscreen

Homosalate 15.0% .............................Sunscreen

Octisalate 5.0% ..................................Sunscreen

Octocrylene 10.0% .............................Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SURFACE SHEER TOUCH SPF 50 WITH FRAGRANCE 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE 20 (UNII: H8YMB5QY0D)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
XANTHAN GUM (UNII: TTV12P4NEE)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
STYRENE (UNII: 44LJ2U959V)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
WATER (UNII: 059QF0KO0R)
4-METHYL-1,4-PENTANEDIYL DIMETHACRYLATE (UNII: 3BHT04VYO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-005-01	177 mL in 1 TUBE; Type 0: Not a Combination Product	12/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/10/2018

Labeler - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-005)