SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN- octinoxate and zinc oxide lotion 
OMP, Inc.

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 ingredients

Octinoxate 7.5%, Zinc Oxide 10.5%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

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 sunscreen with a Broad Spectrum SPF value 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

Inactive ingredients

1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum

Other information

store at controlled room temperature: 15°C–25°C (59°F–77°F)
protect this product from excessive heat and direct sun

Questions or comments?

1.800.636.7546

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

OBAGI®
MEDICAL

Sun Shield

MATTE

Broad
Spectrum
SPF 50

Sunscreen
Lotion

Non-Comedogenic

Dermatologist Tested

Net wt. 3 OZ (85 g)

Sun Shield Broad Spectrum SPF 50 MATTE Sunscreen Lotion - 85g
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE  SUNSCREEN
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TROPOLONE (UNII: 7L6DL16P1T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-125-901 in 1 CARTON02/21/2013
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:62032-125-0515 g in 1 TUBE; Type 0: Not a Combination Product02/21/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/21/2013
Labeler - OMP, Inc. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
Ei INC.105803274MANUFACTURE(62032-125) , LABEL(62032-125) , PACK(62032-125)

Revised: 8/2016
Document Id: 36d4fd66-04d4-4218-a7b6-3c5bc28c134b
Set id: 8ed08c9d-523e-408e-a0ad-7a7cf0fe7aa3
Version: 2
Effective Time: 20160805
 
OMP, Inc.