NARS LAGUNA BODY TINT- avobenzone, homosalate, octinoxate, and octocrylene cream

NARS LAGUNA BODY TINT by

Drug Labeling and Warnings

NARS LAGUNA BODY TINT 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 3%
Homosalate 10%
Octinoxate 7.4%
Octocrylene 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

Water ∙ Glycerin ∙ Propanediol ∙ Butylene Glycol ∙ Decyl Isostearate ∙ Cocos Nucifera (Coconut) Oil ∙ Gardenia Taitensis Flower Extract ∙ Curcuma Longa (Turmeric) Root Extract ∙ Calophyllum Inophyllum Seed Oil ∙ Vanilla Tahitensis Fruit Extract ∙ Isostearyl Isostearate ∙ Acrylates/Beheneth-25 Methacrylate Copolymer ∙ PPG-8-Ceteth-20 ∙ Sorbeth-30 Tetraisostearate ∙ Sorbitan Sesquiisostearate ∙ Polyurethane-35 ∙ Dipropylene Glycol ∙ BHT ∙ Potassium Hydroxide ∙ Trisodium EDTA ∙ Fragrance ∙ Phenoxyethanol ∙ Mica ∙ Titanium Dioxide ∙ Iron Oxides ∙

Other information

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

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

NARS

LAGUNA BODY TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT. 3.8 Oz. 100 mL

INGREDIENTS AND APPEARANCE

NARS LAGUNA BODY TINT 
avobenzone, homosalate, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3300 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	11000 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	8140 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5500 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MICA (UNII: V8A1AW0880)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DECYL ISOSTEARATE (UNII: NRB038QC02)
COCONUT OIL (UNII: Q9L0O73W7L)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TAMANU OIL (UNII: JT3LVK84A1)
EDETATE TRISODIUM (UNII: 420IP921MB)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
VANILLA (UNII: Q74T35078H)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-159-60	1 in 1 CARTON	03/15/2017
1		100 mL 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 NOT FINAL	part352	03/15/2017

Labeler - NARS Cosmetics (837363571)