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Cetaphil DermaControl SPF 30

Dosage form: lotion
Ingredients: Octocrylene 7g in 100mL, Octisalate 5g in 100mL, Avobenzone 3g in 100mL
Labeler: Galderma Laboratories, L.P.
NDC Code: 0299-3913

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients......Purpose

AVOBENZONE 3%......Sunscreen
OCTISALATE 5%........Sunscreen
OCTOCRYLENE 7%....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, not to be swallowed

• 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.
• Keep out of reach of children. If 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.
• 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 from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

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

Other Information

• Protect this product from excessive heat and direct sun.

Questions?

1-866-735-4137

Principle Display Panel

Cetaphil®

DERMACONTROL™

OIL CONTROL

MOISTURIZER

with sunscreen

BROAD SPECTRUM SPF 30

FORMULATED FOR ACNE-PRONE SKIN

Clinically proven to help manage oily skin

Lightweight formula absorbs quickly and provides a matte finish

Non-comedogenic, oil-free and fragrance free

4 FL OZ (118 mL)

GALDERMA

OIL CONTROL

MOISTURIZER

with sunscreen

BROAD SPECTRUM SPF 30

FORMULATED FOR ACNE-PRONE SKIN

OIL CONTROL

MOISTURIZER SPF 30

For Acne-Prone Skin

• Helps control shine
• Works well alone or under make-up
• Clinically tested for tolerability with acne medications
• Dermatologist developed and tested

Importance of Daily Sunscreen protection:

The American Academy of Dermatology recommends using a broad-spectrum sunscreen with an SPF of at least 30 to help prevent sunburn, skin cancer and other skin damage.

HYDRATE, PROTECT AND CONTROL SHINE

with this lightweight 3-in-1 mosturizer. Clinically proven to manage oily, acne-prone skin while providing broad spectrum protection from the sun's harmful rays, this gentle formula absorbs quickly and provides a long-lasting matte finish.

Cetaphil® DermaControl™ is part of a regimen that is clinically proven to manage oily, acne-prone skin.

Step 1: Cleanse daily with Cetaphil® DermaControl™ Oil Control Foam Wash.

Step 2: Moisturize with Cetaphil® DermaControl™ Oil Control Moisterizer SPF 30.

cetaphil.com

Distributed By:
Galderma Laboratories L.P.
Fort Worth, TX 76177
Made in Canada

GALDERMA is a registered trademark.

P51882-1

Cetaphil®

DERMACONTROL™

OIL CONTROL
MOISTURIZER

with sunscreen
BROAD SPECTRUM SPF 30

FORMULATED FOR ACNE-PRONE SKIN

P51880-1

GALDERMA

4 FL OZ (118 mL)

DIRECTIONS

Apply liberally 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours to maintain SPF level.

ACTIVE INGREDIENTS

AVOBENZONE 3%
OCTISALATE 5%
OCTOCRYLENE 7%

Distributed By:
Galderma Laboratories L.P.
Fort Worth, TX 76177

Made in Canada

Galderma is a registered trademark

P51881-1

CETAPHIL DERMACONTROL SPF 30 
octocrylene, octisalate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-3913
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (Octocrylene) Octocrylene7 g  in 100 mL
Octisalate (Octisalate) Octisalate5 g  in 100 mL
Avobenzone (Avobenzone) Avobenzone3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Dimethicone 
Diisopropyl Sebacate 
Silicon Dioxide 
Aluminum Starch Octenylsuccinate 
Pentylene Glycol 
Sodium Stearoyl Glutamate 
Phenoxyethanol 
Caprylyl Glycol 
Alpha-Tocopherol Acetate 
Enoxolone 
Panthenol 
Trolamine 
Allantoin 
Potassium Sorbate 
Zinc Gluconate 
Xanthan Gum 
Edetate Disodium 
Packaging
#Item CodePackage Description
1NDC:0299-3913-041 BOTTLE, PUMP (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE, PUMP
2NDC:0299-3913-017 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/01/2011
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIOperations
G Production Inc.251676961manufacture(0299-3913)

Revised: 01/2015
 
Galderma Laboratories, L.P.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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