Label: NARS RADIANCE PRIMER- avobenzone, homosalate, octisalate, and octocrylene cream
- NDC Code(s): 13734-158-60, 13734-158-61
- Packager: NARS Cosmetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 26, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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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
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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
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
NARS RADIANCE PRIMER
avobenzone, homosalate, octisalate, and octocrylene creamProduct 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)