Active Ingredients...……….....Purpose

Titianium Dioxide 6% .........…..Sunscreen
Zinc Oxide 4.7% ......................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

Do not use

▪ on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs.

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
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

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?

1-866-735-4137

PRINCIPAL DISPLAY PANEL - 0.5 OZ Card

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®

SUN

Sheer Mineral Sunscreen Stick

Broad Spectrum SFP 50

Formulated for sensitive skin, Microbiome gentle,
Water resistant (80 minutes)
Vitamin E

NET WT 0.5 OZ (14 g)
National Eczema Association logo

Distributed by:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA
All trademarks are the property of their respective owners
cetaphil.com
P55345-1

CETAPHIL SHEER MINERAL SUNSCREEN STICK SPF 50
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0299-4108
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	47 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Yellow Wax (UNII: 2ZA36H0S2V)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Candelilla Wax (UNII: WL0328HX19)
Isostearic Acid (UNII: X33R8U0062)
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
Ceresin (UNII: Q1LS2UJO3A)
Paraffin (UNII: I9O0E3H2ZE)
High Density Polyethylene (UNII: UG00KM4WR7)
Stearic Acid (UNII: 4ELV7Z65AP)
.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)
Triethoxycaprylylsilane (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0299-4108-00	1 in 1 BLISTER PACK	11/01/2020
1		14 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/01/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
Fruit of The Earth Research Laboratories, Inc.		008193513	manufacture(0299-4108)

Cetaphil Sheer Mineral Sunscreen Stick Broad Spectrum SPF 50