OBAGI MEDICAL PHYSICAL DEFENSE BROAD SPECTRUM MINERAL SUNSCREEN SPF 50 BY SUZANOBAGIMD- titanium dioxide and zinc oxide cream

Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD by

Drug Labeling and Warnings

Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, G.S.COSMECEUTICAL USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredients
Titanium Dioxide 5.8%	Sunscreen
Zinc Oxide 14.4%	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 doctor if rash occurs

Keep out of reach of children. If product is 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a physician

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Glycerin, Cetearyl Alcohol, Dimethicone, Propanediol, Polyhydroxystearic Acid, Cetearyl Glucoside, Aloe Barbadensis Leaf Extract, Brassica Oleracea Italica (Broccoli) Extract, Bioflavonoids, Dipotassium Glycyrrhizate, Polyglyceryl- 2, Dipolyhydroxystearate, Sodium Stearoyl Glutamate, Sodium C14-16 Olefin Sulfonate Stearic Acid, Lauryl Glucoside, Triethoxycaprylylsilane, Xanthan Gum, Silica, Alumina, Caprylhydroxamic Acid, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)

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

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Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 96.3 g Tube Carton

OBAGI®
MEDICAL

PHYSICAL DEFENSE
50 Broad Spectrum Mineral Sunscreen
SPF 50 PA++++
Lightly Tinted, Lightweight, and Sheer

BY SUZANOBAGIMD™

HEV VIS IR Protection

Net wt. 3.4 oz. (96.3 g)

INGREDIENTS AND APPEARANCE

OBAGI MEDICAL PHYSICAL DEFENSE BROAD SPECTRUM MINERAL SUNSCREEN SPF 50 BY SUZANOBAGIMD 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-608
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	58 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	144 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Glycerin (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Dimethicone (UNII: 92RU3N3Y1O)
Propanediol (UNII: 5965N8W85T)
Cetearyl Glucoside (UNII: 09FUA47KNA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Broccoli (UNII: UOI4FT57BZ)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
Lauryl Glucoside (UNII: 76LN7P7UCU)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Xanthan Gum (UNII: TTV12P4NEE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
Caprylhydroxamic Acid (UNII: UPY805K99W)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Caprylyl Glycol (UNII: 00YIU5438U)
Phenoxyethanol (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-608-35	1 in 1 CARTON	04/01/2020
1		96.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/01/2020

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
G.S.COSMECEUTICAL USA		017014734	MANUFACTURE(62032-608)