NARS RADIANCE PRIMER- avobenzone, homosalate, octisalate, and octocrylene cream

NARS RADIANCE PRIMER by

Drug Labeling and Warnings

NARS RADIANCE PRIMER by is a Otc medication manufactured, distributed, or labeled by NARS Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 2%
Homosalate 6%
Octisalate 5%
Octocrylene 1.6%}

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 ∙ Caprylyl Methicone ∙ Dipropylene Glycol ∙ Propanediol ∙ Dimethicone ∙ Butyloctyl Salicylate ∙ Lactobacillus Ferment ∙ Isododecane ∙ Ammonium Acryloyldimethyltaurate/VP Copolymer ∙ Trisiloxane ∙ Polysorbate 60 ∙ Trimethylsiloxysilicate ∙ Dextrin Palmitate ∙ Phenoxyethanol ∙ C14-22 Alcohols ∙ Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer ∙ Hydrolyzed Wheat Protein/PVP Crosspolymer ∙ Panthenol ∙ Fragrance ∙ Evodia Rutaecarpa Fruit Extract ∙ Dibutyl Ethylhexanoyl Glutamide ∙ Dibutyl Lauroyl Glutamide ∙ Disodium EDTA ∙ C12-20 Alkyl Glucoside ∙ Dipotassium Glycyrrhizate ∙ Tocopheryl Acetate ∙ Sodium Hyaluronate ∙ Butylene Glycol ∙ Pentylene Glycol ∙ Tin Oxide ∙ Potassium Sorbate ∙ Hydroxyphenyl Propamidobenzoic Acid ∙ Ethylhexylglycerin ∙ Ascorbyl Palmitate ∙ Mica ∙ Titanium Dioxide ∙ Red 4 ∙ Yellow 5 ∙

Other information

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

Questions or comments?

Call toll free 1-888-788-NARS

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

NARS

RADIANCE PRIMER
BROAD SPECTRUM
SPF 35 SUNSCREEN

NET WT.
1 Oz. 30 mL

INGREDIENTS AND APPEARANCE

NARS RADIANCE PRIMER 
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	602.4 mg  in 30 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1807.2 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1506 mg  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	481.9 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICA (UNII: V8A1AW0880)
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
TRISILOXANE (UNII: 9G1ZW13R0G)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PANTHENOL (UNII: WV9CM0O67Z)
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STANNIC OXIDE (UNII: KM7N50LOS6)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-158-60	1 in 1 CARTON	12/01/2016
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 13734-158-61	1 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2016

Labeler - NARS Cosmetics (837363571)