NDC Code(s) : 0299-5889-00, 0299-5889-05
Packager : Galderma Laboratories, L.P.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 20titanium dioxide, zinc oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-5889
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE101 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE78 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN(UNII: 344S277G0Z)
BENZYL ALCOHOL(UNII: LKG8494WBH)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CAFFEINE(UNII: 3G6A5W338E)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CHROMIC OXIDE(UNII: X5Z09SU859)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
DIMETHICONE(UNII: 92RU3N3Y1O)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ISOHEXADECANE(UNII: 918X1OUF1E)
Magnesium Sulfate, Unspecified Form(UNII: DE08037SAB)
METHYLPROPANEDIOL(UNII: N8F53B3R4R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TOCOPHEROL(UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TRISILOXANE(UNII: 9G1ZW13R0G)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0299-5889-001 in 1 CARTON 12/09/2016
150 mL in 1 TUBE Type 0: Not a Combination Product
2NDC:0299-5889-0510 mL in 1 TUBE Type 0: Not a Combination Product12/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 12/09/2016

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

Establishment
Name Address ID/FEI Business Operations
Knowlton Development Corporation Inc. 204006464 manufacture(0299-5889)

PRINCIPAL DISPLAY PANEL

#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®

REDNESS
RELIEVING

Daily Facial
Moisturizer
with Sunscreen
BROAD SPECTRUM SPF 20
20

Redness-Prone,
Sensitive Skin
Tinted formula
neutralizes the
appearance of redness
Soothing Allantoin &
Vitamin E
5 Skin Sensitivity Signs

1.7 FL OZ (50 ML)

Distributed by:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA
All trademarks are the property of their
respective owners.
Made in Canada
cetaphil.com
P55123-2