OTC Medication Information: Obagi Sun Shield TINT Warm Sunscreen Broad Spectrum SPF 50

OBAGI SUN SHIELD TINT WARM SUNSCREEN BROAD SPECTRUM SPF 50- homosalate, octinoxate, 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.

Drug Facts

Active ingredients Purpose

Homosalate 10%

Octinoxate 7.5%

Titanium dioxide 3.22%

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
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
children under 6 months: ask a doctor

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, Butylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Behenyl Alcohol, Physalis Angulata Extract, Dimethicone, PEG-40 Stearate, Phenoxyethanol, Lithothamnion Calcareum Powder, Glycerin, Mica, Sodium Stearoyl Lactylate, Polyhydroxystearic Acid, Mannitol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Citric Acid, Squalane, Xanthan Gum, Alumina, Stearic Acid, Diatomaceous Earth, Sodium Polyacrylate, Disodium EDTA, Ethylhexylglycerin, Synthetic Fluorphlogopite, Polysorbate 60, Zinc Sulfate, Sorbitan Oleate, Chlorphenesin, Tetrahexyldecyl Ascorbate, Tocopherol, Tin Oxide, Iron Oxides

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

Broad
Spectrum
SPF 50
Sunscreen
Lotion

WARM
TINT

Infrared
Defense

Non-comedogenic
Dermatologist tested

Net wt. 3 oz. (85 g)

PRINCIPAL DISPLAY PANEL -- 85 g Tube Carton
(click image for full-size original)
OBAGI SUN SHIELD TINT WARM SUNSCREEN BROAD SPECTRUM SPF 50
homosalate, octinoxate, titanium dioxide, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-160
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 8.5 g in 85 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 6.375 g in 85 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.737 g in 85 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4.25 g in 85 g
Inactive Ingredients
Ingredient Name Strength
WATER
BUTYLOCTYL SALICYLATE
MEDIUM-CHAIN TRIGLYCERIDES
CAPRYLYL TRISILOXANE
12-OXOOCTADECANOIC ACID
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
BUTYLENE GLYCOL
PENTYLENE GLYCOL
DOCOSANOL
FERRIC OXIDE RED
PEG-40 STEARATE
DIMETHICONE
PHYSALIS ANGULATA WHOLE
PHENOXYETHANOL
FUCUS VESICULOSUS
GLYCERIN
MICA
SODIUM STEAROYL LACTYLATE
POLYHYDROXYSTEARIC ACID (2300 MW)
MANNITOL
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
ANHYDROUS CITRIC ACID
SQUALANE
ALUMINUM OXIDE
STEARIC ACID
XANTHAN GUM
DIATOMACEOUS EARTH
SODIUM POLYACRYLATE (2500000 MW)
EDETATE DISODIUM
ETHYLHEXYLGLYCERIN
POLYSORBATE 60
ZINC SULFATE, UNSPECIFIED FORM
CHLORPHENESIN
TETRAHEXYLDECYL ASCORBATE
STANNIC OXIDE
TOCOPHEROL
EDETATE DISODIUM ANHYDROUS
FERROUS OXIDE
PHYMATOLITHON CALCAREUM
POLYGLYCERYL-10 PENTASTEARATE
SORBITAN MONOOLEATE
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE
ZINC SULFATE MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-160-10 1 TUBE in 1 CARTON contains a TUBE
1 85 g in 1 TUBE This package is contained within the CARTON (62032-160-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 12/01/2019
Labeler — Obagi Cosmeceuticals LLC (790553353)
Establishment
Name Address ID/FEI Operations
Swiss-American CDMO, LLC 080170933 MANUFACTURE (62032-160)

Revised: 02/2021 Obagi Cosmeceuticals LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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