Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 73ed545b-460f-4287-8643-a02b0641fd45
Route
TOPICAL
Published
Effective Date 2024-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octisalate (5 g) Octocrylene (7 g)
Inactive Ingredients
Allantoin Aluminum Starch Octenylsuccinate Caprylyl Glycol Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) Ceramide Np Diisopropyl Sebacate Dimethicone Dimethiconol (2000 Cst) Edetate Disodium Glycerin Enoxolone Isopropyl Lauroyl Sarcosinate Panthenol Pentylene Glycol Phenoxyethanol Poly(methyl Methacrylate; 450000 Mw) Polysorbate 61 Potassium Sorbate Silicon Dioxide Sodium Hydroxide Sodium Stearoyl Glutamate Sucrose Tristearate .alpha.-tocopherol Water Xanthan Gum Zinc Gluconate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

Description

AVOBENZONE 3% OCTISALATE 5% OCTOCRYLENE 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3% OCTISALATE 5% OCTOCRYLENE 7%

Use(s)
  • 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.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes.

Rinse with water to remove.

Directions

• Apply liberally 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating.

• Reapply at least every 2 hours.

• Children under 6 months: Ask a doctor.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of 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 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Questions?

1-866-735-4137

Distributed By:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics
Active Ingredients

AVOBENZONE 3%

OCTISALATE 5%

OCTOCRYLENE 7%

Inactive Ingredients

Allantoin, Aluminum Starch Octenylsuccinate, Caprylyl Glycol, Carbomer, Ceramide NP, Diisopropyl Sebacate, Dimethicone, Dimethiconol, Disodium EDTA, Glycerin, Glycyrrhetinic Acid, Isopropyl Lauroyl Sarcosinate, Panthenol, Pentylene Glycol, Phenoxyethanol, Polymethyl Methacrylate, Polysorbate 61, Potassium Sorbate, Silica, Sodium Hydroxide, Sodium Stearoyl Glutamate, Sucrose Tristearate, Tocopheryl Acetate, Water, Xanthan Gum, Zinc Gluconate

Keep Out of Reach of Children

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

Principle Display Panel 4oz Carton



NEW LOOK



Cetaphil®



OILY SKIN

DermaControlTM

Oil Absorbing

Moisturizer


30 BROAD SPECTRUM

     SPF 30 (UVA/UVB)

     SUNSCREEN

Clinically proven to reduce shine

and hydrate with less irritation 

Glycerin, Vitamins E & B5



AM

Dermatologist Recommended

Sensitive Skin



4 FL OZ (118 mL)



P57733-0


Structured Label Content

Use(s)
  • 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.
Purpose

Sunscreen

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.

Directions

• Apply liberally 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating.

• Reapply at least every 2 hours.

• Children under 6 months: Ask a doctor.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of 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 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Questions?

1-866-735-4137

Distributed By:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics
Active Ingredients (Active ingredients)

AVOBENZONE 3%

OCTISALATE 5%

OCTOCRYLENE 7%

Inactive Ingredients

Allantoin, Aluminum Starch Octenylsuccinate, Caprylyl Glycol, Carbomer, Ceramide NP, Diisopropyl Sebacate, Dimethicone, Dimethiconol, Disodium EDTA, Glycerin, Glycyrrhetinic Acid, Isopropyl Lauroyl Sarcosinate, Panthenol, Pentylene Glycol, Phenoxyethanol, Polymethyl Methacrylate, Polysorbate 61, Potassium Sorbate, Silica, Sodium Hydroxide, Sodium Stearoyl Glutamate, Sucrose Tristearate, Tocopheryl Acetate, Water, Xanthan Gum, Zinc Gluconate

Keep Out of Reach of Children (Keep out of reach of children)

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

Principle Display Panel 4oz Carton (PRINCIPLE DISPLAY PANEL - 4oz carton)



NEW LOOK



Cetaphil®



OILY SKIN

DermaControlTM

Oil Absorbing

Moisturizer


30 BROAD SPECTRUM

     SPF 30 (UVA/UVB)

     SUNSCREEN

Clinically proven to reduce shine

and hydrate with less irritation 

Glycerin, Vitamins E & B5



AM

Dermatologist Recommended

Sensitive Skin



4 FL OZ (118 mL)



P57733-0


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)