NARS AFTERGLOW LIP BALM CLEAN CUT- octinoxate stick

NARS AFTERGLOW LIP BALM CLEAN CUT by

Drug Labeling and Warnings

NARS AFTERGLOW LIP BALM CLEAN CUT by is a Otc medication manufactured, distributed, or labeled by NARS Cosmetics, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.4%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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　

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor

Inactive ingredients

Hydrogenated Polyisobutene ∙ Triisostearin ∙ Squalane ∙ Bis-Diglyceryl Polyacyladipate-2 ∙ Diphenylsiloxy Phenyl Trimethicone ∙ Polyethylene ∙ Microcrystalline Wax ∙ Diisostearyl Malate ∙ Cocos Nucifera (Coconut) Oil ∙ Tocopherol ∙ Gardenia Taitensis Flower Extract ∙ Tocopheryl Acetate ∙ Simmondsia Chinensis (Jojoba) Seed Oil ∙ Punica Granatum Flower Extract ∙ Polysilicone-2 ∙ Glyceryl Diisostearate ∙ Simethicone ∙ Trimethylolpropane Triethylhexanoate ∙ Lauryl PCA ∙ Methicone ∙ Tetradecene ∙ Tin Oxide ∙ BHT ∙ Silica ∙ Aluminum Hydroxide ∙ Phenoxyethanol ∙ Titanium Dioxide ∙ Iron Oxides ∙ Red 7 Lake ∙

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 - 3 g Cartridge Carton

NARS

AFTERGLOW LIP BALM
SPF 10 SUNSCREEN

NET WT. 0.1 Oz. 3 g

INGREDIENTS AND APPEARANCE

NARS AFTERGLOW LIP BALM CLEAN CUT 
octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	222 mg  in 3 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TRIISOSTEARIN (UNII: 71503RH8KG)
SQUALANE (UNII: GW89575KF9)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
JOJOBA OIL (UNII: 724GKU717M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-160-20	1 in 1 CARTON	02/01/2019
1		3 g in 1 CARTRIDGE; 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	02/01/2019

Labeler - NARS Cosmetics (837363571)