FDA.reportPublic FDA data

Cetaphil Sheer Mineral Sunscreen Stick SPF 50

Manufacturer
Galderma Laboratories, L.P. | Fruit of The Earth Research Laboratories, Inc.
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:53:54

Label at a glance#

ProductCetaphil Sheer Mineral Sunscreen Stick SPF 50
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure11 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 reapply:   after 80 minutes of swimming or sweating immediately after towel drying 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 p...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titianium Dioxide 6% 
Zinc Oxide 4.7% 

Purpose

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

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
  • reapply:  
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • 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
▪ protect the product in this container from excessive heat and direct sun
▪ may stain or damage some fabrics


Inactive Ingredients

INACTIVE INGREDIENT SECTION

ALUMINUM HYDROXIDE, BEESWAX, BHT, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CETYL ALCOHOL, DIMETHICONE, EUPHORBIA CERIFERA (CANDELILLA) WAX, ISOSTEARIC ACID, NEOPENTYL GLYCOL DIETHYLHEXANOATE, OZOKERITE, PARAFFIN, POLYETHYLENE, STEARIC ACID, TOCOPHERYL ACETATE (VITAMIN E), TRIETHOXYCAPRYLYLSILANE

Questions or comments?

OTC - QUESTIONS SECTION

1-866-735-4137

PRINCIPAL DISPLAY PANEL - 0.5 OZ Card

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P55345-2 card art
P55345-2 card art

Cetaphil®

SUN

50

Sheer Mineral Sunscreen Stick

Broad Spectrum SPF 50

All Skin Types

Locks in moisture to hydrate
Water resistant (80 minutes)

100% Mineral UVA/UVB Filters &
Antioxidant Vitamin E


NET WT 0.5 OZ (14 g)

National Eczema Association logo

Distributed by:
Galderma Laboratories, L.P.
Dallas, TX 75201 USA
All trademarks are the property of their respective owners
cetaphil.com
P55345-2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4108-00Cetaphil Sheer Mineral Sunscreen Stick SPF 5014 g in 1 CANISTERSTICK145
0299-4108-00Cetaphil Sheer Mineral Sunscreen Stick SPF 501 in 1 BLISTER PACKSTICK15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4108CETAPHIL SHEER MINERAL SUNSCREEN STICK SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) STICK [GALDERMA LABORATORIES, L.P.]5Current NDC, Legacy NDC, 2 package rows20250130_54f6df65-e90c-4070-aa95-f47496dd11bd.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0299-41080299-4108-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Aluminum Hydroxide5QB0T2IUN0IACT
Yellow Wax2ZA36H0S2VIACT
Butylated Hydroxytoluene1P9D0Z171KIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Cetyl Alcohol936JST6JCNIACT
Dimethicone92RU3N3Y1OIACT
Candelilla WaxWL0328HX19IACT
Isostearic AcidX33R8U0062IACT
Neopentyl Glycol DiethylhexanoateU68ZV6W62CIACT
CeresinQ1LS2UJO3AIACT
ParaffinI9O0E3H2ZEIACT
High Density PolyethyleneUG00KM4WR7IACT
Stearic Acid4ELV7Z65APIACT
.Alpha.-Tocopherol Acetate, D-A7E6112E4NIACT
TriethoxycaprylylsilaneLDC331P08EIACT

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 Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
ndc (package): 0299-4108-00
ndc (product): 0299-4108
ndc11 (package): 00299410800
spl id: ab57ebb2-15e4-4b3d-ba5a-d5bc099bde04
spl set id: 54f6df65-e90c-4070-aa95-f47496dd11bd

Reported adverse events (FAERS/openFDA)#

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