OBAGI SUN SHIELD TINT COOL SUNSCREEN BROAD SPECTRUM SPF 50- homosalate, octinoxate, titanium dioxide, 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.

----------

OBAGI®
Sun Shield TINT Cool Sunscreen
Broad Spectrum SPF 50

Drug Facts

Active ingredientsPurpose

Homosalate 10%

Octinoxate 7.5%

Titanium dioxide 3.18%

Sunscreen

Sunscreen

Sunscreen

Zinc oxide 5%

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
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

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

Other information

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

Inactive ingredients

water, butyloctyl salicylate, caprylic/capric triglyceride, caprylyl methicone, polyglyceryl-10 pentastearate, glyceryl stearate, PEG-100 stearate, butylene glycol, pentylene glycol, behenyl alcohol, PEG-40 stearate, dimethicone, physalis angulata extract, algae extract, glycerin, iron oxides, phenoxyethanol, sodium stearoyl lactylate, polyhydroxystearic acid, mannitol, mica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, squalane, alumina, stearic acid, xanthan gum, calcium aluminium borosilicate, diatomaceous earth, Sodium Polyacrylate, disodium EDTA, synthetic fluorphlogopite, polysorbate 60, ethylhexylglycerin, zinc sulfate, Sorbitan Oleate, silica, chlorphenesin, tetrahexyldecyl ascorbate, tin oxide, tocopherol

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

TINT

COOL

Broad
Spectrum
SPF 50
Sunscreen
Lotion

Infrared
Defense

Non-comedogenic
Dermatologist tested

Net wt. 3 oz. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
OBAGI  SUN SHIELD TINT COOL SUNSCREEN BROAD SPECTRUM SPF 50
homosalate, octinoxate, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8.5 g  in 85 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.375 g  in 85 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.703 g  in 85 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.25 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
12-OXOOCTADECANOIC ACID (UNII: 31GL7GRO8F)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DOCOSANOL (UNII: 9G1OE216XY)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)  
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
MANNITOL (UNII: 3OWL53L36A)  
MICA (UNII: V8A1AW0880)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SQUALANE (UNII: GW89575KF9)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROUS OXIDE (UNII: G7036X8B5H)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-150-101 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(62032-150)

Revised: 2/2021
Document Id: e88579ae-c406-470e-8283-169bf3a42fcb
Set id: 6456fc28-3df5-4d49-9f40-8ef2e4fdd9e5
Version: 3
Effective Time: 20210211
 
Obagi Cosmeceuticals LLC