CITY SUNSCREEN SERUM BROAD SPECTRUM SPF 30 SUPERGOOP- homosalate, octisalate, avobenzene, octocrylene cream

City Sunscreen serum Broad Spectrum SPF 30 by

Drug Labeling and Warnings

City Sunscreen serum Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Baxter Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Purpose

Homosalate 8%, Octisalate 4%, Avobenzene 3%, Octocrylene 2% Sunscreen

PURPOSE

Purpose

Uses Simultaneously protects skin, combats premature aging and moisturizes on contact

helps prevent sunburn

If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging skin aging caused by the sun

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

WARNINGS

Warnings

For external use only.

Do not use on damaged or broken skin

When using this product, keep out of of eyes.

Rinse with water to remove.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions: Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

children under 6 months: ask a doctor

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 sunscreenwith Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

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

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

INACTIVE INGREDIENT

Inactive Ingredients Purified water (Aqua), Cyclometicone, Isostearyl Neopentanoate, Glycerin, Ceteareth-20, Polypropylene, Cetearyl Alcohol, Xanthan Gum, d-Panthenol, Octanohydroxamic acid, Caprylyl Glycol, Silica, Triacontanyl PVP, Cetyl Dimethicone, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-40 Stearate, Tocopheryl, Disodium EDTA, Pentylene Glycol, Pantheyl Triacetate, Sodium Lactate, Lactic Acid, Serine, Urea, Sorbitol, Sodium Chloride, Allantoin, Oleyl Alcohol, Ethyl Linoleate.

PRINCIPAL DISPLAY PANEL

City Sunscreen

SERUM

With Vitamins E & B5

Supergoop!

3 ml

INGREDIENTS AND APPEARANCE

CITY SUNSCREEN SERUM BROAD SPECTRUM SPF 30  SUPERGOOP
homosalate, octisalate, avobenzene, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
PANTHENOL (UNII: WV9CM0O67Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM LACTATE (UNII: TU7HW0W0QT)
LACTIC ACID (UNII: 33X04XA5AT)
SERINE (UNII: 452VLY9402)
UREA (UNII: 8W8T17847W)
SORBITOL (UNII: 506T60A25R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALLANTOIN (UNII: 344S277G0Z)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70157-003-01	3 mL in 1 PACKET; Type 0: Not a Combination Product	12/07/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/07/2010

Labeler - Baxter Laboratories (740537709)

Registrant - Baxter Laboratories (740537709)

Establishment
Name	Address	ID/FEI	Business Operations
Qualis Packaging Inc		078387992	label(70157-003)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories		740537709	manufacture(70157-003)