NARS SMOOTH AND PROTECT PRIMER- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

NARS SMOOTH and PROTECT PRIMER by

Drug Labeling and Warnings

NARS SMOOTH and PROTECT 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 2.5%
Homosalate 10%
Octisalate 5%
Octocrylene 5%
Oxybenzone 5%

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

Dimethicone ∙ Methyl Trimethicone ∙ Dimethicone/Vinyl Dimethicone Crosspolymer ∙ Dimethicone Crosspolymer ∙ Disteardimonium Hectorite ∙ Polymethylsilsesquioxane ∙ Silica ∙ Trimethylsiloxysilicate ∙ HDI/Trimethylol Hexyllactone Crosspolymer ∙ PEG-10 Dimethicone ∙ PEG/PPG-19/19 Dimethicone ∙ Hydrogenated Polyisobutene ∙ Tocopherol ∙ Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer ∙ VP/Eicosene Copolymer ∙ Dipropylene Glycol ∙ Water ∙ Lavandula Angustifolia (Lavender) Extract ∙ Dimethylmethoxy Chromanol ∙ Trisodium EDTA ∙ Tin Oxide ∙ Mica ∙ Titanium Dioxide ∙

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

SMOOTH & PROTECT
PRIMER
BROAD SPECTRUM
SPF 50 SUNSCREEN

NET WT.
1 Oz. 30 mL

INGREDIENTS AND APPEARANCE

NARS SMOOTH AND PROTECT PRIMER 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	741.7 mg  in 30 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2967 mg  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1483.5 mg  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1483.5 mg  in 30 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1483.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
WATER (UNII: 059QF0KO0R)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
EDETATE TRISODIUM (UNII: 420IP921MB)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-157-60	1 in 1 CARTON	12/01/2016
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 13734-157-61	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)