Obagi®

Obagi®
SPL v3
SPL
SPL Set ID ff95a7b7-3cb4-41b0-866d-69361354a0bc
Route
TOPICAL
Published
Effective Date 2021-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (58 mg) Zinc Oxide (144 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Dicaprylyl Carbonate Glycerin Cetostearyl Alcohol Dimethicone Propanediol Cetearyl Glucoside Aloe Vera Leaf Broccoli Citrus Bioflavonoids Glycyrrhizinate Dipotassium Sodium Stearoyl Glutamate Lauryl Glucoside Triethoxycaprylylsilane Xanthan Gum Silicon Dioxide Aluminum Oxide Caprylhydroxamic Acid Edetate Disodium Anhydrous Caprylyl Glycol Phenoxyethanol Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active Ingredients
Titanium Dioxide 5.8% Sunscreen
Zinc Oxide 14.4% Sunscreen
Warnings

For external use only

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
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 (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)

Questions Or Comments?

1.800.636.7546

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

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)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active Ingredients
Titanium Dioxide 5.8% Sunscreen
Zinc Oxide 14.4% Sunscreen
Warnings

For external use only

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
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 (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)

Questions Or Comments? (Questions or comments?)

1.800.636.7546

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

Principal Display Panel 96.3 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

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