SUN SHIELD BROAD SPECTRUM SPF 50 MATTE  SUNSCREEN- homosalate, octisalate, and zinc oxide lotion 
Obagi Cosmeceuticals LLC

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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SUN SHIELD BROAD SPECTRUM SPF 50 MATTE
SUNSCREEN LOTION

Drug Facts

Active ingredientsPurpose
Homosalate 10%Sunscreen
Octisalate 5%Sunscreen
Zinc Oxide 16.5%Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

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

Directions

Other information

Inactive ingredients

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

Questions or comments?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

OBAGI®
MEDICAL

Sun Shield

MATTE

Broad
Spectrum
SPF 50

Sunscreen
Lotion

Non-Comedogenic
Dermatologist Tested

Net wt. 3 oz (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE   SUNSCREEN
homosalate, octisalate, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE165 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Hydroxyacetophenone (UNII: G1L3HT4CMH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
C15-19 Alkane (UNII: CI87N1IM01)  
Disteardimonium Hectorite (UNII: X687XDK09L)  
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
Sorbitan Olivate (UNII: MDL271E3GR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Candelilla Wax (UNII: WL0328HX19)  
Yellow Wax (UNII: 2ZA36H0S2V)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-140-34479 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/2019
2NDC:62032-140-091 in 1 CARTON07/15/2019
285 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:62032-140-0528 g in 1 TUBE; Type 0: Not a Combination Product07/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/15/2019
Labeler - Obagi Cosmeceuticals LLC (790553353)
Establishment
NameAddressID/FEIBusiness Operations
Swiss American CDMO, LLC080170933MANUFACTURE(62032-140)

Revised: 9/2019
Document Id: a2859154-a41c-472b-aced-7a77f609c2f2
Set id: 263ef8e8-e0c4-42e6-bb26-7581a437b35a
Version: 2
Effective Time: 20190905
 
Obagi Cosmeceuticals LLC