Obagi®

Obagi®
SPL v2
SPL
SPL Set ID aa937596-2378-469f-a0e1-9700044e83b3
Route
TOPICAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Octisalate (5 g) Zinc Oxide (16.5 g)
Inactive Ingredients
1,2-hexanediol C15-19 Alkane Candelilla Wax Caprylyl Glycol Dimethicone Disteardimonium Hectorite Edetate Disodium Anhydrous Glycerin Hydroxyacetophenone Octyldodecyl Neopentanoate Polyglyceryl-2 Isostearate Polyglyceryl-6 Polyricinoleate Polyhydroxystearic Acid (2300 Mw) Polymethylsilsesquioxane (4.5 Microns) Silicon Dioxide Sodium Chloride Sodium Hydroxide Sorbitan Olivate Triethoxycaprylylsilane Water Xanthan Gum Yellow Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01
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 swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a 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 Purpose
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Zinc Oxide 16.5% 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 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 (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (Candelilla) Wax, Beeswax (Cera Alba), Dimethicone

Questions Or Comments?

1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. PST

Principal Display Panel Kit Carton

BACK to BASICS

OBAGI®

MEDICAL

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 swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a 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 Purpose
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Zinc Oxide 16.5% 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 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 (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 (Inactive ingredients)

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (Candelilla) Wax, Beeswax (Cera Alba), Dimethicone

Questions Or Comments? (Questions or comments?)

1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. PST

Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

BACK to BASICS

OBAGI®

MEDICAL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:51.368367 · Updated: 2026-03-14T23:08:14.770901