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

Cetaphil Sheer Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Titianium Dioxide 9.0% 
Zinc Oxide 7.0% 

OTC - PURPOSE SECTION

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

WATER, ISOHEXADECANE, BUTYLOCTYL SALICYLATE, CETYL DIMETHICONE, STYRENE/ACRYLATES COPOLYMER, OLIVE OIL POLYGLYCERYL-6 ESTERS, SORBITAN OLIVATE, SODIUM STEAROYL LACTYLATE, VP/EICOSENE COPOLYMER, CETEARYL ALCOHOL, CETEARYL OLIVATE, CETYL PALMITATE, SORBITAN PALMITATE, DIMETHICONE PEG-8 LAURATE, CERAMIDE NP, CERAMIDE AP, CERAMIDE EOP, CHOLESTEROL, PHYTOSPHINGOSINE, HYDROLYZED HYALURONIC ACID, BENZYL ALCOHOL, BISABOLOL, DIPOTASSIUM GLYCYRRHIZATE, PROPANEDIOL, XANTHAN GUM, ALUMINUM HYDROXIDE, SODIUM LAUROYL LACTYLATE, CARBOMER, TOCOPHERYL ACETATE, DISODIUM EDTA, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, CITRIC ACID, MALTODEXTRIN, PHENOXYETHANOL, CAPRYLOYL GLYCINE, UNDECYLENOYL GLYCINE

Questions or comments?

1-866-735-4137

PRINCIPAL DISPLAY PANEL - 3 FL OZ TUBE

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®  
SUN
50
 

Sheer Mineral Sunscreen

Broad Spectrum SPF 50

Formulated for sensitive skin

Microbiome gentle formula

nourishes sensitive skin while
providing hydrating,
chemical-free sun protection

Water resistant (80 minutes)

Prebiotics & Vitamin E

National Eczema Association logo

3 FL OZ (89 mL)

Distributed by:

Galderma Laboratories, L.P.

Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

cetaphil.com
P55348-1

INGREDIENTS AND APPEARANCE

CETAPHIL SHEER MINERAL SUNSCREEN SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	90 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Isohexadecane (UNII: 918X1OUF1E)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Cetyl Dimethicone 150 (UNII: 5L694Y0T22)
Styrene/Acrylamide Copolymer (500000 Mw) (UNII: 5Z4DPO246A)
Olive Oil Polyglyceryl-6 Esters (UNII: 4KDO9AFM9I)
Sorbitan Olivate (UNII: MDL271E3GR)
Sodium Stearoyl Lactylate (UNII: IN99IT31LN)
Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetearyl Olivate (UNII: 58B69Q84JO)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
Sorbitan Monopalmitate (UNII: 77K6Z421KU)
Dimethicone Peg-8 Laurate (UNII: 72MF9C2A18)
Ceramide Np (UNII: 4370DF050B)
Ceramide Ap (UNII: F1X8L2B00J)
Ceramide 1 (UNII: 5THT33P7X7)
Cholesterol (UNII: 97C5T2UQ7J)
Phytosphingosine (UNII: GIN46U9Q2Q)
Benzyl Alcohol (UNII: LKG8494WBH)
Levomenol (UNII: 24WE03BX2T)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Propanediol (UNII: 5965N8W85T)
Xanthan Gum (UNII: TTV12P4NEE)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Sodium Lauroyl Lactylate (UNII: 7243K85WFO)
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Edetate Disodium (UNII: 7FLD91C86K)
Stearic Acid (UNII: 4ELV7Z65AP)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Maltodextrin (UNII: 7CVR7L4A2D)
Phenoxyethanol (UNII: HIE492ZZ3T)
Capryloyl Glycine (UNII: 8TY5YO42NJ)
Undecylenoyl Glycine (UNII: 4D20464K2J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4122-00	89 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of The Earth Research Laboratories, Inc.		008193513	manufacture(0299-4122)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of The Earth, Inc.		080086802	manufacture(0299-4122)