NARS PRO-PRIME MULTI-PROTECT PRIMER- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

NARS PRO-PRIME MULTI-PROTECT PRIMER by

Drug Labeling and Warnings

NARS PRO-PRIME MULTI-PROTECT PRIMER by is a Otc medication manufactured, distributed, or labeled by NARS Cosmetics, SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

AVOBENZONE 3%
HOMOSALATE 10%
OCTISALATE 3%
OCTOCRYLENE 2.5%
OXYBENZONE 4%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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 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

Water Neopentyl Glycol Diheptanoate Cetyl Dimethicone Cetyl PEG/PPG-10/1 Dimethicone Disteardimonium Hectorite Silica Polyglyceryl-2 Diisostearate Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer Dipropylene Glycol Butylene Glycol HDI/Trimethylol Hexyllactone Crosspolymer Sodium Chloride Isostearic Acid Phenoxyethanol Ethylhexylglycerin Trisodium EDTA Citrus Aurantium Dulcis (Orange) Oil Tocopherol Tocopheryl Acetate Boswellia Serrata Gum Butyrospermum Parkii (Shea) Seedcake Extract Gentiana Urnula Flower Extract

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-888-788-NARS

SPL UNCLASSIFIED SECTION

NARS™
NARS COSMETICS
NEW YORK, NY 10022 DIST.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

NARS

PRO-PRIME™

MULTI-PROTECT PRIMER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1 Oz. 30 mL

INGREDIENTS AND APPEARANCE

NARS PRO-PRIME MULTI-PROTECT PRIMER 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	922 mg  in 30.72 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3072 mg  in 30.72 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	922 mg  in 30.72 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	768 mg  in 30.72 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1229 mg  in 30.72 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE TRISODIUM (UNII: 420IP921MB)
ORANGE OIL (UNII: AKN3KSD11B)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
GENTIANA URNULA FLOWER (UNII: 2RIZ3HY23X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-101-60	1 in 1 CARTON
1		30.72 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

Labeler - NARS Cosmetics (837363571)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(13734-101) , ANALYSIS(13734-101)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(13734-101)