SKINPERFECT PRIMER SPF 30- titanium dioxide and zinc oxide lotion

SkinPerfect Primer by

Drug Labeling and Warnings

SkinPerfect Primer by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., McKenna, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Use

• helps prevent sunburn.
• if used as directed with other sun protection measures (see Directions), helps decrease 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 30 minutes before sun exposure
• reapply:
  • at least every two hours
  • use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses
• Children under 6 months: ask a doctor

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

• Protect this product from excessive heat and direct sun

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®

INGREDIENTS AND APPEARANCE

SKINPERFECT PRIMER   SPF 30
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	140 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-130-02	1 in 1 CARTON	02/13/2012
1		22 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-130-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	02/13/2012
3	NDC: 68479-130-04	50 mL in 1 POUCH; Type 0: Not a Combination Product	02/13/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/13/2012

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-130)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-130)