CETAPHIL SHEER MINERAL FACE LIQUID SUNSCREEN SPF 50- zinc oxide lotion

Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 by

Drug Labeling and Warnings

Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 12% 

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

• shake well
• 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

Inactive Ingredients

ALLANTOIN, BISABOLOL, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAPRYLYL GLYCOL, CAPRYLYL METHICONE, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, ISODODECANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, LAURYL PEG-8 DIMETHICONE, NIACINAMIDE, OCTYLDODECYL NEOPENTANOATE, PEG-10, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, PROPANEDIOL, SODIUM CHLORIDE,SODIUM HYDROXIDE, TETRASODIUM GLUTAMATE DIACETATE, TOCOPHEROL (VITAMIN E), TRILAURETH-4 PHOSPHATE, WATER

Questions or comments?

1-866-735-4137

PRINCIPAL DISPLAY PANEL - 1.7 FL OZ CARTON

DERMATOLOGIST RECOMMENDED
FOR SENSITIVE SKIN

Cetaphil®   SUN  
 50   

Sheer Mineral Face
Liquid Sunscreen

Broad Spectrum SPF 50

Formulated for sensitive skin

1.7 FL OZ (50 mL)

Distributed by:
Galderma Laboratories, L.P.
Dallas, TX 75201 USA
All trademarks are the property of their respective owners.
cetaphil.com
P55342-1

PRINCIPAL DISPLAY PANEL - 1.7 FL OZ FRONT LABEL

Cetaphil®

SUN
50

Sheer Mineral Face
Liquid Sunscreen
Broad Spectrum SPF 50

 

Formulated for sensitive skin
Microbiome gentle
Water resistant (80 minutes)
Ideal for use under makeup
Vitamin E

1.7 FL OZ (50mL)
P55341-1

INGREDIENTS AND APPEARANCE

CETAPHIL SHEER MINERAL FACE LIQUID SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Allantoin (UNII: 344S277G0Z)
Levomenol (UNII: 24WE03BX2T)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Caprylyl Glycol (UNII: 00YIU5438U)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer (450000000 Mw) (UNII: 9KB5R958PB)
Ethylhexylglycerin (UNII: 147D247K3P)
Hexylene Glycol (UNII: KEH0A3F75J)
Isododecane (UNII: A8289P68Y2)
Niacinamide (UNII: 25X51I8RD4)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Polyethylene Glycol 500 (UNII: 761NX2Q08Y)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Propanediol (UNII: 5965N8W85T)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
Tocopherol (UNII: R0ZB2556P8)
Trilaureth-4 Phosphate (UNII: M96W2OLL2V)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4110-00	1 in 1 CARTON	11/01/2020
1		50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0299-4110-05	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020

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
Nanophase Technologies Corporation		623502044	manufacture(0299-4110)