SURFACE SUN ACTIVE DEFENSE SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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 2%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

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:

after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours.

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

Water, Propylene Glycol, Neopentyl Glycol Diheptanoate, Polyamide-8, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Chlorphenesin, Disodium EDTA, Oleth-3, Triethanolamine, Fragrance.

Label

Surface Sun Active Defense SPF 30

SURFACE SUN ACTIVE DEFENSE SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72344-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
OLETH-3 (UNII: BQZ26235UC)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHLORPHENESIN (UNII: I670DAL4SZ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72344-007-06	177 mL in 1 TUBE; Type 0: Not a Combination Product	03/14/2018

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

Labeler - Surface Products Corp (010777036)

Registrant - CGI Packaging, LLC (080691099)

Name	Address	ID/FEI	Business Operations
Establishment
CGI Packaging, LLC		080691099	manufacture(72344-007)