NARS PRO-PRIME LIGHT OPTIMIZING PRIMER- octinoxate, avobenzone, and octocrylene cream

NARS PRO-PRIME LIGHT OPTIMIZING PRIMER by

Drug Labeling and Warnings

NARS PRO-PRIME LIGHT OPTIMIZING 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]

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Drug Facts

Active ingredients

Avobenzone 2.5%
Octinoxate 5.9%
Octocrylene 2%

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 ∙ Butylene Glycol ∙ Dimethicone ∙ Dipropylene Glycol ∙ Silica ∙ Glycerin ∙ Polysorbate 60 ∙ Behenyl Alcohol ∙ Phenoxyethyl Caprylate ∙ Sorbitan Stearate ∙ Phenoxyethanol ∙ Ethylhexylglycerin ∙ Fragrance ∙ Chlorphenesin ∙ Acrylates/C10-30 Alkyl Acrylate Crosspolymer ∙ Potassium Hydroxide ∙ Carbomer ∙ Xanthan Gum ∙ Sea Water ∙ Palmaria Palmata Extract ∙ Trisodium EDTA ∙ Algae Extract ∙ Ascorbic Acid ∙ Retinyl Palmitate ∙ Tocopheryl Acetate ∙ BHT ∙ Barium Sulfate ∙ Potassium Sorbate ∙ Citric Acid ∙ Alumina ∙ Mica ∙ Titanium Dioxide ∙ Iron Oxides ∙

Other information

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

Questions or comments?

Call toll free 1-888-788-NARS

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NARS COSMETICS, NEW YORK, NY 10022 DIST.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

NARS

PRO-PRIME™

LIGHT OPTIMIZING PRIMER
BROAD SPECTRUM
SPF 15 SUNSCREEN

NET WT.
1.1 Oz. 30 mL

INGREDIENTS AND APPEARANCE

NARS PRO-PRIME LIGHT OPTIMIZING PRIMER 
octinoxate, avobenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	63 mg  in 1.072 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1.072 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	21 mg  in 1.072 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DOCOSANOL (UNII: 9G1OE216XY)
PHENOXYETHYL CAPRYLATE (UNII: GMI5AN7T8U)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DULSE (UNII: 7832HOY4ZQ)
EDETATE TRISODIUM (UNII: 420IP921MB)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-113-60	1 in 1 CARTON
1		32.16 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 13734-113-61	1 in 1 CARTON
2		2.144 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 13734-113-80	1.072 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 13734-113-62	1 in 1 CARTON
4		8.576 g in 1 TUBE; Type 0: Not a Combination Product

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(13734-113) , ANALYSIS(13734-113)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(13734-113)