SURFACE SUN WETSKIN FORMULA SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Surface Sun Wetskin Formula SPF 30 Sunscreen by

Drug Labeling and Warnings

Surface Sun Wetskin Formula SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Surface Products Corp, CGI Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%, Homosalate 8%, Octisalate 4%, Octocrylene 8%, Oxybenzone 5%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only.

Flammable: do not use near heat, flame, or while smoking. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Keep away from face to avoid breathing it. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F. 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

Spray liberally and evenly by hand 15 minutes before sun exposure.

Reapply after:

80 minutes of sweating or swimming

immediately after towel drying

at least every 2 hours

Hold can 4-6 inches from the skin to apply. Do not spray directly into your face. Spray on hands an then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.

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:

Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: ask a doctor.

Inactive Ingredients

Acrylates/Dimethicone Copolymer, Acrylates Octylacrylamide Copolymer, Alcohol Denat., Ascorbyl Palmitate, Cyclopentasiloxane, Fragrance, Neopentyl Glycol Diheptanoate, Octyldodecyl Citrate Crosspolymer, Polyester-7, Polyester-8, Retinyl Palmitate, Tocopheryl Acetate.

Label

INGREDIENTS AND APPEARANCE

SURFACE SUN WETSKIN FORMULA SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72344-006
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
POLYESTER-7 (UNII: 0841698D2F)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72344-006-06	170 mL in 1 CAN; Type 0: Not a Combination Product	03/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/14/2018

Labeler - Surface Products Corp (010777036)

Registrant - CGI Packaging, LLC (080691099)

Establishment
Name	Address	ID/FEI	Business Operations
CGI Packaging, LLC		080691099	manufacture(72344-006)