SUN SHIELD MINERAL BROAD SPECTRUM SPF 50  SUNSCREEN- titanium dioxide 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 MINERAL BROAD SPECTRUM SPF 50
SUNSCREEN LOTION

Drug Facts

Active ingredientsPurpose
Titanium dioxide 6.2%Sunscreen
Zinc oxide 15.6%Sunscreen

Uses

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.

Stop use and ask a doctor if rash occurs

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

Directions

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Pentylene Glycol, Steareth-2, Glycerin, Silica, Polyhydroxystearic Acid, Steareth-21, Cetearyl Alcohol, Propanediol, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Caprylyl Glycol, Triethoxycaprylylsilane, Cetearyl Glucoslde, Xanthan Gum, Dipotassium Glycyrrhizate, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Tropaeolum Majus Flower/Leaf/Stem Extract

Other information

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
MINERAL
Broad
Spectrum
SPF 50

Sunscreen
Lotion

PA++++
Non-comedogenic
Dermatologist Tested

Net wt. 3 oz. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
SUN SHIELD MINERAL BROAD SPECTRUM SPF 50   SUNSCREEN
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-811
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide6.2 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide15.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PROPANEDIOL (UNII: 5965N8W85T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-811-091 in 1 CARTON12/01/2019
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/01/2019
Labeler - Obagi Cosmeceuticals LLC (790553353)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933MANUFACTURE(62032-811)

Revised: 2/2021
Document Id: 5c7fbfd0-d6f8-43ff-a171-199e48a10339
Set id: c0d229c8-ff22-47ca-9aed-8e3bdebc3fb1
Version: 1
Effective Time: 20210204
 
Obagi Cosmeceuticals LLC