FDA.reportPublic FDA data

Cetaphil Daily Facial Moisturizer with suncreen SPF 50

Manufacturer
Galderma Laboratories, L.P. | G Production Inc.
Effective date
2024-04-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:11:15

Label at a glance#

ProductCetaphil Daily Facial Moisturizer with suncreen SPF 50
Active ingredientOCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5% 
Octisalate 5% 
Octocrylene 7% 
Oxybenzone 6% 
Titanium Dioxide 5.7% 

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert:

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown to help prevent sunburn, not skin cancer or early aging.

SPL UNCLASSIFIED SECTION

For external use only.

OTC - WHEN USING SECTION

Do not use on damaged or broken skin.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

SPL UNCLASSIFIED SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Glycerin, Dimethicone, VP/Eicosene Copolymer ,Cyclohexasiloxane, Stearic Acid, Potassium Cetyl Phosphate, Dimethiconol, Glyceryl Stearate, PEG-100 Stearate, Aluminum Hydroxide, Disodium EDTA, Tocopherol, Phenoxyethanol, Ethylparaben, Chlorphenesin, Cetyl Alcohol, Acrylates/C10-30 Alkyl Acrylate, Crosspolymer, Methylparaben, Xanthan Gum, Sodium Hydroxide

Other Information

SPL UNCLASSIFIED SECTION

• Protect this product from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

1-866-735-4137

Principal Display Panel - 1.7oz carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P57749-0 carton
P57749-0 carton

NEW LOOK

Cetaphil®

Daily Facial
Moisturizer
AM

50 SPF 50
     Sunscreen

All Skin Types

Rich lotion hydrates
and protects skin

Glycerin, Vitamin E

Oil Free

Dermatologist Recommended
Sensitive Skin

1.7 FL OZ (50 mL)

Distributed by:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

P57749-0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4930-02Cetaphil Daily Facial Moisturizer with suncreen SPF 501 in 1 CARTONLOTION17
0299-4930-02Cetaphil Daily Facial Moisturizer with suncreen SPF 5050 mL in 1 TUBELOTION507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4930CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 50 (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) LOTION [GALDERMA LABORATORIES, L.P.]7Current NDC, Legacy NDC, 2 package rows20240420_6650d137-e69e-4ec2-8311-3de74bf21315.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN01
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
EthylparabenINACTIVE INGREDIENT14255EXE391
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
PEG-100 StearateINACTIVE INGREDIENTYD01N1999R1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Potassium Cetyl PhosphateINACTIVE INGREDIENT03KCY6P7UT1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
TocopherolINACTIVE INGREDIENTR0ZB2556P81
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-49300299-4930-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
Cyclomethicone 6XHK3U310BAIACT
STEARIC ACID4ELV7Z65APIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Dimethiconol (40 Cst)343C7U75XWIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
EDETATE DISODIUM7FLD91C86KIACT
TOCOPHEROLR0ZB2556P8IACT
PhenoxyethanolHIE492ZZ3TIACT
Ethylparaben14255EXE39IACT
ChlorphenesinI670DAL4SZIACT
Cetyl Alcohol936JST6JCNIACT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.S)8Z5ZAL5H3VIACT
MethylparabenA2I8C7HI9TIACT
Xanthan GumTTV12P4NEEIACT
Sodium Hydroxide55X04QC32IIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Aluminum HydroxideALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii+route
4 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 StearatePEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39GRANULE, FOR SOLUTION / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
Aluminum HydroxideALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii+route
4 equally ranked IID candidates
TocopherolTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39POWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
8 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39SUSPENSION / ORAL8 mgExact identifier — unii candidate
8 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TocopherolTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Aluminum HydroxideALUMINUM HYDROXIDE5QB0T2IUN0OINTMENT / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39POWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
8 equally ranked IID candidates
PEG-100 StearatePEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39GRANULE, FOR SOLUTION / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39SUSPENSION / ORAL8 mgExact identifier — unii candidate
8 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Aluminum HydroxideALUMINUM HYDROXIDE5QB0T2IUN0OINTMENT / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
ndc (package): 0299-4930-02
ndc (product): 0299-4930
ndc11 (package): 00299493002
spl id: 0a1d0295-47d8-41f4-aaeb-5692637df0f1
spl set id: 6650d137-e69e-4ec2-8311-3de74bf21315

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.