SOFT FOCUS CITY SUNCREEN SERUM BROAD SPECTRUM SPF 30 SUPERGOOP- avobenzone, homosalate, octisalate, octocrylene liquid

Soft Focus City Suncreen Serum Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Soft Focus City Suncreen Serum Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients         Purpose

Avobenzone 3%            Sunscreen

Homosalate 8%            Sunscreen

Octisalate 4%               Sunscreen

Octocrylene 2%            Sunscreen  

PURPOSE

Uses Helps prevent sunburn

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

stop use and ask a doctor if rash occurs

WARNINGS

Warnings

​For External Use only

Do not use on damaged or broken skin

​When using this product keep out of eyes. Rinse with water to remove.

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

DOSAGE & ADMINISTRATION

Directions

Apply two pumps to face and neckat least 15 minutes prior to sun exposure. Oil-free and fast absorbing, it's ideal for use alone or as a smoothing primer under the rest of your skincare regimen.  Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients Aqua, Cyclopentasilosiloxane, Isostearyl Neopentanoate, Glycerin, Cyclohexasiloxane, Ceteareth-20, Polypropylene, Cetearyl Alcohol, Caprylyl Glycol, Xanthan Gum, PEG-40 Stearate, Triacontanyl PVP, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Panthenyl Triacetate, Cetyl Dimethicone, Ethyl Linoleate, Caprylhydroxamic Acid, Oleyl Alcohol, Tocopherol, Disodium EDTA, Panthenol, Triethanolamine, Pentylene Glycol, Sodium Lactate, Lactic Acid, Serine, Urea, Sorbitol, Sodium Chloride, Allantoin, CI 77492, CI77491, CI77499

PRINCIPAL DISPLAY PANEL

Supergoop!

City Sunscreen Serum With vitamins E & B5

Broad Spectrum SPF 30

Soft Focus Finish

Lightweight, Anti-aging Serum moisturizes and repairs while protecting from premature photoaging

1.7 fl. oz. / 60 ml

INGREDIENTS AND APPEARANCE

SOFT FOCUS CITY SUNCREEN SERUM BROAD SPECTRUM SPF 30  SUPERGOOP
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-005
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-40 STEARATE (UNII: ECU18C66Q7)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTHENOL (UNII: WV9CM0O67Z)
TROLAMINE (UNII: 9O3K93S3TK)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70157-005-02	1 in 1 CARTON	12/30/2014
1	NDC: 70157-005-01	60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/30/2014

Labeler - Baxter Laboratories Pty. Ltd. (740537709)

Registrant - Baxter Laboratories Pty. Ltd. (740537709)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	manufacture(70157-005)