REDNESS RELIEF PRIMER  SPF20- titanium dioxide and zinc oxide lotion 
Dermalogica, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Redness Relief Primer
SPF20

Drug Facts

Active ingredients

Titanium Dioxide (3.0%),
Zinc Oxide (8.5%).

Purpose

Sunscreen

Use

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

Other information

Inactive ingredients

Cyclopentasiloxane, Isododecane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Caprylyl Methicone, Lauryl PEG-10 Tris (Trimethylsiloxy) Silylethyl Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Cross polymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Water/Aqua/Eau, Polyhydroxystearic Acid, Avena Sativa (Oat) Kernel Oil, Bisabolol, Saccharomyces Lysate Extract, Zingiber Officinale (Ginger) Root Extract, Boerhavia Diffusa Root Extract, Melia Azadirachta Seed Extract, Melia Azadirachta Leaf Extract, Avena Sativa (Oat) Kernel Extract, Amber Powder, Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant) Fruit Extract, Ocimum Basilicum (Basil) Leaf Extract, Curcuma Longa (Tumeric) Leaf Extract, Pearl Powder, Dodecene, Hydroxyphenyl Propamidobenzoic Acid, Silica Dimethyl Silylate, Dimethicone, Butylene Glycol, Pentylene Glycol, Glycerin, Alumina, PEG-10, Stearic Acid, Triethoxycaprylylsilane, Ethylhexylglycerin, Ascorbyl Palmitate, Potassium Sorbate, Phenoxyethanol, Iron Oxides CI 77492, CI 77499.

Questions or comments?

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

redness
relief
primer

spf
20

broad
spectrum

UVA medium protection

UltraCalming

0.75 US FL OZ / 22 mL e

dermalogica®

PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton
REDNESS RELIEF PRIMER   SPF20
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide85 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Isododecane (UNII: A8289P68Y2)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer (UNII: O4I3UFO6ZF)  
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
Water (UNII: 059QF0KO0R)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Oat Kernel Oil (UNII: 3UVP41R77R)  
Levomenol (UNII: 24WE03BX2T)  
Saccharomyces Lysate (UNII: R85W246Z1C)  
Ginger (UNII: C5529G5JPQ)  
Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
Azadirachta Indica Seed (UNII: P1NV46V59R)  
Azadirachta Indica Leaf (UNII: HKY915780T)  
Oat (UNII: Z6J799EAJK)  
Amber (UNII: 70J9Z0J26P)  
Coccinia Grandis Fruit (UNII: VLJ6WOT3K5)  
Eggplant (UNII: W5K7RAS4VK)  
Basil (UNII: 2U0KZP0FDW)  
Curcuma Longa Leaf (UNII: H2HC4RY52C)  
Pearl (Hyriopsis Cumingii) (UNII: A75L5FZ40U)  
Dodecene (UNII: WYE669F3GR)  
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)  
Dimethicone (UNII: 92RU3N3Y1O)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Pentylene Glycol (UNII: 50C1307PZG)  
Glycerin (UNII: PDC6A3C0OX)  
Aluminum Oxide (UNII: LMI26O6933)  
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-009-021 in 1 CARTON
122 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-009-002 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/21/2014
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
PakLab790530976MANUFACTURE(68479-009)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-009)

Revised: 11/2015
Document Id: f3bda8f6-6898-4818-bdfb-c01eca8b7516
Set id: f421522a-49c0-4cd7-b0c7-ce304ca3939f
Version: 2
Effective Time: 20151119
 
Dermalogica, Inc.