CETAPHIL- octocrylene, avobenzone lotion

Cetaphil by

Drug Labeling and Warnings

Cetaphil by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., G Production Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active IngredientsActive IngredientsActive Ingredients

Avobenzone 3%
Octocrylene 10%

PurposePurposePurpose

Avobenzone..........Sunscreen
Octocrylene..........Sunscreen

Use(s)Use(s)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.

WarningsWarningsWarnings

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.

Keep out of reach of children.

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

DirectionsDirectionsDirections

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 – 2 pm.
Wear long-sleeved shirts, pants, hats, and sun glasses.

INACTIVE INGREDIENTS:

Water, Diisopropyl Adipate, Cyclomethicone, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polymethyl Methacrylate, Phenoxyethanol, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Carbomer 940, Disodium EDTA, Triethanolamine.

Other Information

Protect this product from excessive heat and direct sun.
May stain some fabrics.

Questions?

1-866-735-4137

PRINCIPAL DISPLAY PANEL

                    

Cetaphil®

Daily Facial
Moisturizer

with sunscreen

BROAD SPECTRUM SPF 15

Face All skin types

Hydrates, nourishes and protects

UVA/UVB Protection

Non-comedogenic

Fragrance free

Lightweight, non-greasy

4 FL OZ (118mL)

Cetaphil

Daily Facial

Moisturizer

with sunscreen

BROAD SPECTRUM

SPF 15

FOR ALL SKIN TYPES

This light, non-greasy moisturizer nourishes and hydrates your skin while protecting it from the sun's harmful rays.

Restores and improves your skin's ability to retain vital moisture.

Non-comedogenic

Fragrance free / PABA free

Dermatologist recommended

Actual size

Cetaphil

Daily Facial

Moisturizer

with sunscreen

BROAD SPECTRUM

SPF 15

FOR ALL SKIN TYPES

Importance of daily sunscreen protection:

UV rays from the sun are made of UVA and UVB. It is important to protect against both UVA and UVB to help prevent sunburn and other skin damage. Also, broad spectrum sunscreen protection helps decrease early signs of aging caused by the sun when used with other sun protection measures.

Use in combination with a complete regimen of Cetaphil cleansers and moisturizers for your daily skin care needs.

Distributed by:
Galderma Laboratories, L.P.
Fort Worth, Texas 76177 USA

Cetaphil is a registered trademark of Galderma.

Made in Canada

cetaphil.com
P50935-5

LOT:

EXP:

Cetaphil®

MEN

Daily Face Lotion

with sunscreen

BROAD SPECTRUM SPF 15

Face For all skin types

Soothes sensitive skin even post-shave

Hydrates and protects skin without clogging pores

4 FL OZ (118 mL)

Cetaphil MEN

Daily Face Lotion

with sunscreen

BROAD SPECTRUM

SPF 15

Protect your skin from harsh outdoor elements and the effects of your razor.

This lightweight formula absorbs quickly and locks in moisture to strengthen skin's natural moisture barrier.  Broad spectrum SPF 15 protection helps decrease early signs of aging caused by the sun when used with other sun protection measures. Perfect for post-shave, it also soothes sensitive skin. The result is healthy, hydrated skin all day or night long. Use after cleansing with Cetaphil Men Daily Face Wash.

Won't clog pores.

Non-irritating.

No fragrance.

Dermatologist developed and tested.

Actual Size

Cetaphil® MEN

Daily Face Lotion

with sunscreen

BROAD SPECTRUM

SPF 15

Importance of daily sunscreen protection:

UV rays from the sun are made of UVA and UVB. It is important to protect against both UVA and UVB to help prevent sunburn.

Distributed by:

Galderma Laboratories L.P.

Fort Worth, TX 76177 USA

CETAPHIL is a registered trademark of GALDERMA.

Made in Canada

cetaphil.com
P52833-0

INGREDIENTS AND APPEARANCE

CETAPHIL  
octocrylene, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-3928
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-3928-04	1 in 1 CARTON	04/01/2000
1		118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 0299-3928-07	1 in 1 CARTON	02/01/2015	07/01/2019
2		118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2000

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	MANUFACTURE(0299-3928)