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

Cetaphil Sheer Mineral Sunscreen Stick SPF 50 by

Drug Labeling and Warnings

Cetaphil Sheer Mineral Sunscreen Stick SPF 50 by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Fruit of The Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titianium Dioxide 6% 
Zinc Oxide 4.7% 

Purpose

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

SPL UNCLASSIFIED SECTION

Questions or comments?

1-866-735-4137

PRINCIPAL DISPLAY PANEL - 0.5 OZ Card

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2020

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

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