obagi medical way to glow kit

obagi medical way to glow kit
SPL v2
SPL
SPL Set ID f6f6e219-4ef6-be3b-e053-6294a90a660d
Route
topical
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (50 mg) homosalate (100 mg) zinc oxide (165 mg)
Inactive Ingredients
polyglyceryl-2 isostearate polymethylsilsesquioxane (4.5 microns) 1,2-hexanediol caprylyl glycol disteardimonium hectorite edetate disodium anhydrous sodium chloride c15-19 alkane dimethicone glycerin polyglyceryl-6 polyricinoleate polyhydroxystearic acid (2300 mw) silicon dioxide sodium hydroxide yellow wax hydroxyacetophenone octyldodecyl neopentanoate candelilla wax sorbitan olivate triethoxycaprylylsilane water xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-03-20

Description

Drug Facts


Medication Information

Warnings
  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.
Active Ingredient
Active ingredients Purpose

Homosalate 10%

Sunscreen

Octisalate 5%

Sunscreen

Zinc Oxide 16.5%

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

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
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, Dimethicone

Description

Drug Facts

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 55105-1

Sunscreen

Principal Display Panel Kit Carton

Way to

Glow

Defend, Hydrate & Protect

OBAGI®

MEDICAL


Structured Label Content

Warnings
  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.
Active Ingredient (55106-9)
Active ingredients Purpose

Homosalate 10%

Sunscreen

Octisalate 5%

Sunscreen

Zinc Oxide 16.5%

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

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
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, Dimethicone

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 55105-1 (55105-1)

Sunscreen

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

Way to

Glow

Defend, Hydrate & Protect

OBAGI®

MEDICAL


Advanced Ingredient Data


Raw Label Data

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