LAURA MERCIER FOUNDATION PRIMER PROTECT  BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, octinoxate, octocrylene, and oxybenzone cream 
Laura Mercier Cosmetics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Laura Mercier Foundation Primer Protect
Broad Spectrum SPF 30 Sunscreen

Drug Facts

Active ingredients

Avobenzone (3.0%), Octinoxate (7.3%), 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 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 of age: Ask a doctor

Other information

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

Inactive ingredients

Water, Glycerin, Isohexadecane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Xanthan Gum, Polysorbate 80, Ethylhexylglycerin, Tocopherol, Disodium EDTA, PEG-8, Ascorbyl Palmitate, Citric Acid, Ascorbic Acid. May Contain (+/-): Yellow 5, Red 6.

Questions or comments?

Call 1-888-637-2437, M – F 9am – 5pm CST.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

laura mercier

FOUNDATION PRIMER
PROTECT
BROAD SPECTRUM
SPF 30 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
LAURA MERCIER FOUNDATION PRIMER PROTECT   BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-368
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1500 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3650 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1500 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1000 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-368-601 in 1 CARTON04/11/201411/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/11/201411/30/2021
Labeler - Laura Mercier Cosmetics (193691821)

Revised: 11/2021
Document Id: c68a1243-069c-468a-9365-e751b219999c
Set id: f2535eb1-b3c1-4bdf-b9ea-81bf83b0bb78
Version: 2
Effective Time: 20211129
 
Laura Mercier Cosmetics