NARS RADIANCE PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN- octisalate, octocrylene, avobenzone, homosalate lotion

NARS Radiance Primer Broad Spectrum SPF 35 Sunscreen by

Drug Labeling and Warnings

NARS Radiance Primer Broad Spectrum SPF 35 Sunscreen by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Homosalate 6%

Octisalate 5%

Octocrylene 1.6%

Avobenzone 2%

PURPOSE

Purpose

Sunscreen

USES

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 cause by the sun

Warnings

Warnings

For extenal use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

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 INGREDIENT

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

Other information

• Protect the product in this container from excessive heat and direct sun

QUESTIONS or COMMENTS

Questions or comments?

Call toll free 1-888-788-NARS

PRINCIPAL DISPLAY PANEL

Packaging

INGREDIENTS AND APPEARANCE

NARS RADIANCE PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN 
octisalate, octocrylene, avobenzone, homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.6 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PROPANEDIOL (UNII: 5965N8W85T)
STANNIC OXIDE (UNII: KM7N50LOS6)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-159-01	1 in 1 CARTON	06/01/2023
1		30 mg 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 Drug	M020	06/01/2023

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-159)