FDA.reportPublic FDA data

Cetaphil Hydrating Face Sunscreen SPF 35

Manufacturer
Galderma Laboratories, L.P. | ENGLEWOOD LAB, INC.
Effective date
2023-10-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:58:35

Label at a glance#

ProductCetaphil Hydrating Face Sunscreen SPF 35
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure12 sections

Indications and 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

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 of age: Ask a doctor 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.8% .................Sunscreen
Homosalate 9.5% .....................Sunscreen
Octisalate 4.8% ..................Sunscreen
Octocrylene 7% .................Sunscreen

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 of age: Ask a doctor
  • 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

Other information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Dipropylene Glycol, Panthenol (Vitamin B5), Ethylhexyl Methoxycrylene, lsopropyl Palmitate, Silica, Niacinamide, Cetearyl Olivate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E Acetate), Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Leontopodium Alpinum Flower/Leaf Extract, 1,2-Hexanediol, Oryza Saliva (Rice) Lees Extract, Propanediol, Sodium Hydroxide, Adenosine, Citric Acid, Myristic Acid, Tocopherol (Vitamin E), Buddleja Davidii (Summer Lilac) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract

Questions or comments?

OTC - QUESTIONS SECTION

1-866-735-4137

Principal Display Panel - 3 FL OZ Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydrating face sunscreen
hydrating face sunscreen

NEW
DERMATOLOGIST RECOMMENDED
FOR SENSITIVE SKIN

Cetaphil®

SUN
35

Hydrating Face
Sunscreen
Broad Spectrum SPF 35

Formulated for sensitive skin

Oil-free, lightweight
sunscreen hydrates and 
protects against
sun damage

Antioxidant Vitamins B3 and E
plus Vitamin B5

Skin Cancer Foundation logo

3 FL OZ (88 mL)


Distributed by:
Galderma Laboratories, L.P.
Dallas, Texas 75201 USA
All trademarks are the property of their respective owners.
cetaphil.com
P57554-0

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4142-00Cetaphil Hydrating Face Sunscreen SPF 351 in 1 CARTONLOTION11
0299-4142-00Cetaphil Hydrating Face Sunscreen SPF 3588 mL in 1 BOTTLE, PUMPLOTION881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4142CETAPHIL HYDRATING FACE SUNSCREEN SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [GALDERMA LABORATORIES, L.P.]1Current NDC, 2 package rows20231101_e924bfd5-d64d-4918-b57b-7d4da28bd013.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-41420299-4142-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Dipropylene GlycolE107L85C40IACT
PanthenolWV9CM0O67ZIACT
Ethylhexyl MethoxycryleneS3KFG6Q5X8IACT
Isopropyl Palmitate8CRQ2TH63MIACT
Silicon DioxideETJ7Z6XBU4IACT
Niacinamide25X51I8RD4IACT
Cetearyl Olivate58B69Q84JOIACT
Cetostearyl Alcohol2DMT128M1SIACT
Glyceryl Monostearate230OU9XXE4IACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Sorbitan OlivateMDL271E3GRIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Caprylyl Glycol00YIU5438UIACT
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked)59TL3WG5COIACT
Palmitic Acid2V16EO95H1IACT
Ethylhexylglycerin147D247K3PIACT
Stearic Acid4ELV7Z65APIACT
Leontopodium Nivale Subsp. Alpinum Flowering TopQQC1AK06RKIACT
1,2-HexanediolTR046Y3K1GIACT
Rice Germ7N2B70SFEZIACT
Propanediol5965N8W85TIACT
Sodium Hydroxide55X04QC32IIACT
AdenosineK72T3FS567IACT
Citric Acid Monohydrate2968PHW8QPIACT
Myristic Acid0I3V7S25AWIACT
TocopherolR0ZB2556P8IACT
Buddleja Davidii LeafX380815D32IACT
Thymus Vulgaris LeafGRX3499643IACT

Source Document#

Source XML

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 Hydrating Face Sunscreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.e924bfd5-d64d-4918-b57b-7d4da28bd0132023-10-24WarningsExact identifier
ndc (package): 0299-4142-00
ndc (product): 0299-4142
ndc11 (package): 00299414200
spl id: 6eb7c1fe-9c87-4330-a245-e20a0f66aa56
spl set id: e924bfd5-d64d-4918-b57b-7d4da28bd013

Reported adverse events (FAERS/openFDA)#

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