Cetaphil Sheer Mineral Sunscreen Broad Spectrum SPF 50

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]

CETAPHIL SHEER MINERAL SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion 
Galderma Laboratories, L.P.

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Cetaphil Sheer Mineral Sunscreen Broad Spectrum SPF 50

Active Ingredients

Titianium Dioxide 4.9% 
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

alumina, arachidyl alcohol, arachidyl glucoside, ascorbic acid, avena sativa (oat) kernel extract, beeswax, behenyl alcohol, benzyl alcohol, bisabolol, butylene glycol, butyloctyl salicylate, calendula officinalis flower extract, camellia sinensis leaf extract, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetyl dimethicone, chamomilla recutita (matricaria) flower extract, cholesterol, dimethicone, dimethicone PEG-8 laurate, dipotassium glycyrrhizate, disodium EDTA,  ethylhexylglycerin, glycerin, glyceryl stearate, hydrated silica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, methicone, panthenol, pantothenic acid, PEG-100 stearate, PEG-8, phytosphingosine, polyaminopropyl biguanide, polymethyl methacrylate, polysorbate 60, potassium sorbate, propylene glycol, sodium lauroyl lactylate, stearic acid, styrene/acrylates copolymer, tocopheryl acetate(vitamin E), triethoxycaprylylsilane, trimethylsiloxysilicate, trisiloxane, VP/eicosene copolymer, water, xanthan gum.

Questions or comments?

1-866-735-4137

PRINCIPAL DISPLAY PANEL - 3 FL OZ TUBE

NEW 

Cetaphil® 
Dermatologist Recommended Brand

Sheer Mineral
Sunscreen
Broad Spectrum SPF 50
50
 

Formulated for Sensitive Skin

Microbiome Gentle

Contains prebiotics and Vitamin E

Water Resistant (80 minutes)

Paraben and Fragrance Free

3 FL OZ (89 mL)

Distributed by:

Galderma Laboratories, L.P.

Fort Worth, TX 76177 USA
1-866-735-4137

All trademarks are the property of their respective owners.

cetaphil.com
P54713-0

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	49 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	47 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Oat (UNII: Z6J799EAJK)
Yellow Wax (UNII: 2ZA36H0S2V)
Docosanol (UNII: 9G1OE216XY)
Benzyl Alcohol (UNII: LKG8494WBH)
Levomenol (UNII: 24WE03BX2T)
Butylene Glycol (UNII: 3XUS85K0RA)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
Ceramide Ap (UNII: F1X8L2B00J)
Ceramide 1 (UNII: 5THT33P7X7)
Ceramide Np (UNII: 4370DF050B)
Cetyl Dimethicone 150 (UNII: 5L694Y0T22)
Chamomile (UNII: FGL3685T2X)
Cholesterol (UNII: 97C5T2UQ7J)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethicone Peg-8 Laurate (UNII: 72MF9C2A18)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Edetate Disodium (UNII: 7FLD91C86K)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Hydrated Silica (UNII: Y6O7T4G8P9)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.S At 1.5%) (UNII: 86FQE96TZ4)
Isohexadecane (UNII: 918X1OUF1E)
Maltodextrin (UNII: 7CVR7L4A2D)
Methicone (20 Cst) (UNII: 6777U11MKT)
Panthenol (UNII: WV9CM0O67Z)
Pantothenic Acid (UNII: 19F5HK2737)
Peg-100 Stearate (UNII: YD01N1999R)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Phytosphingosine (UNII: GIN46U9Q2Q)
Polihexanide (UNII: 322U039GMF)
Poly(Methyl Methacrylate; 450000 Mw) (UNII: Z47NNT4J11)
Polysorbate 60 (UNII: CAL22UVI4M)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Lauroyl Lactylate (UNII: 7243K85WFO)
Stearic Acid (UNII: 4ELV7Z65AP)
Styrene/Acrylamide Copolymer (500000 Mw) (UNII: 5Z4DPO246A)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Trimethylsiloxysilicate (M/Q 0.6-0.8) (UNII: 5041RX63GN)
Trisiloxane (UNII: 9G1ZW13R0G)
Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4112-00	89 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2020	09/20/2024
2	NDC: 0299-4112-05	10 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2020	09/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2020	09/20/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of The Earth Research Laboratories, Inc.		008193513	manufacture(0299-4112)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of The Earth, Inc.		080086802	manufacture(0299-4112)

Revised: 9/2024

Document Id: 4f839878-e3e4-432e-9dca-3ca00fdcf3fd

34390-5

Set id: d591983f-0a0d-41d4-9b3d-b38216257912

Version: 5

Effective Time: 20240916