LAURA MERCIER PURE CANVAS PRIMER PROTECTING BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate, octocrylene, avobenzone, and oxybenzone cream

Laura Mercier Pure Canvas Primer Protecting Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Laura Mercier Pure Canvas Primer Protecting Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Laura Mercier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

AVOBENZONE 3.0%

OCTINOXATE 7.29%

OCTOCRYLENE 3.0%

OXYBENZONE 2.0%

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 value 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

WATER, GLYCERIN, ISOHEXADECANE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, XANTHAN GUM, POLYSORBATE 80, ETHYLHEXYLGLYCERIN, TOCOPHEROL, DISODIUM EDTA, PEG-8, BHT, ASCORBYL PALMITATE, CITRIC ACID, ASCORBIC ACID, PHENOXYETHANOL.MAY CONTAIN: RED 6, YELLOW 5.

Other information

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

Questions or comments?

Call toll free 1-888-637-2437 M – F 9am – 5pm CST

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

LAURA MERCIER
PARIS | NEW YORK

PURE CANVAS PRIMER

Protecting
Broad Spectrum

SPF 30 Sunscreen

Silicone-free

50 mL / 1.7 FL. OZ. LIQ. US

INGREDIENTS AND APPEARANCE

LAURA MERCIER PURE CANVAS PRIMER PROTECTING BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate, octocrylene, avobenzone, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-823
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.681 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.515 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.515 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.010 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-823-60	1 in 1 CARTON	11/30/2021
1		50 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 final	part352	11/30/2021

Labeler - Laura Mercier Cosmetics (193691821)