SKINPERFECT PRIMER  SPF 30- 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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SkinPerfect Primer
SPF 30

Drug Facts

Active Ingredients

Titanium Dioxide (4.0%), Zinc Oxide (14.0%).

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

Inactive ingredients

Cyclopentasiloxane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Diisopropyl Adipate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Silica, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Water/Aqua/Eau, Arginine/Lysine Polypeptide, Camellia Sinensis Leaf Extract, Palmitoyl Dipeptide-5, Diaminobutyroyl Hydroxythreonine, Palmitoyl Dipeptide-5 Diaminohydroxybutyrate, Sodium Hyaluronate, Hydrolyzed Soy Protein, Silanetriol, Hydrolyzed Pearl, Lavendula Spica (Lavender) Flower Oil, Lavandula Hybrida Oil, Eucalyptus Globulus Leaf Oil, Sodium PCA, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, PEG/PPG-18/18 Dimethicone, PEG/PPG-20/15 Dimethicone, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Tin Oxide, Iron Oxides CI77491, CI77492, CI77499.

Other information

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

skinperfect
primer

spf
30

broad
spectrum

AGE smart®

0.75 US Fl. Oz.
22 mL e

dermalogica®

Principal Display Panel - 22 mL Tube Carton
SKINPERFECT PRIMER   SPF 30
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide140 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Diisopropyl Adipate (UNII: P7E6YFV72X)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Calcium Carbonate (UNII: H0G9379FGK)  
Silanetriol (UNII: E52D0J3TS5)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Lavandin Oil (UNII: 9RES347CKG)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Stearic Acid (UNII: 4ELV7Z65AP)  
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
PEG/PPG-20/15 Dimethicone (UNII: 06R6X77P9C)  
Glycerin (UNII: PDC6A3C0OX)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Stannic Oxide (UNII: KM7N50LOS6)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-130-021 in 1 CARTON02/13/2012
122 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-130-002 mL in 1 POUCH; Type 0: Not a Combination Product02/13/2012
3NDC:68479-130-0450 mL in 1 POUCH; Type 0: Not a Combination Product02/13/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35202/13/2012
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
McKenna090631412MANUFACTURE(68479-130)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-130)

Revised: 12/2017
Document Id: adb2dff4-e406-4123-9624-2d0c12bcb6ef
Set id: 5fc75cef-5b76-44ab-891a-7b90c04a0681
Version: 3
Effective Time: 20171205
 
Dermalogica, Inc.