NYX PROFESSIONAL MAKEUP BARE WITH ME DAILY MOISTURIZING PRIMER WITH CANNABIS SATIVA SEED OIL SPF 30- avobenzone, homosalate, octisalate and octocrylene cream

NYX Professional Makeup Bare With Me Daily Moisturizing Primer with Cannabis Sativa Seed Oil SPF 30 by

Drug Labeling and Warnings

NYX Professional Makeup Bare With Me Daily Moisturizing Primer with Cannabis Sativa Seed Oil SPF 30 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
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 value of 15 or higher and other sun protection measures including:
   o limit time in the sun, especially from 10 a.m. – 2 p.m.
   o wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

water, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, cannabis sativa seed oil, stearic acid, phenoxyethanol, palmitic acid, ammonium polyacryloyldimethyl taurate, steareth-100, phenylethyl resorcinol, caprylyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, fragrance, sodium hyaluronate, tocopherol, dipropylene glycol, ascorbyl glucoside, myristic acid, sodium palmitoyl proline, sodium hydroxide, centella asiatica extract, butylene glycol, linalool, geraniol, limonene, nymphaea alba flower extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NYX PROFESSIONAL MAKEUP BARE WITH ME DAILY MOISTURIZING PRIMER WITH CANNABIS SATIVA SEED OIL SPF 30 
avobenzone, homosalate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITIC ACID (UNII: 2V16EO95H1)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
STEARETH-100 (UNII: 4OH5W9UM87)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
MYRISTIC ACID (UNII: 0I3V7S25AW)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-217-01	1 in 1 CARTON	04/01/2020
1		75 mL in 1 BOTTLE, PUMP; 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	04/01/2020

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-217)