LAURA MERCIER FOUNDATION PRIMER PROTECT SPF 30- avobenzone, octinoxate, octocrylene, oxybenzone lotion 
Gurwitch Products, LLC

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 SPF 30

Drug Facts


Active ingredients

Avobenzone 3.0%, Octinoxate 7.3%, Octocrylene 3.0%, Oxybenzone 2.0%

Purpose

Sunscreen

Uses

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

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 (+/): Red 6, Yellow 5.

Questions or comments?

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

FOUNDATION PRIMER PROTECT

FOUNDATION PRIMER - PROTECT IS A LIGHTWEIGHT, GEL-CREME TEXTURE THAT CREATES THE PERFECT CANVAS FOR MAKEUP APPLICATION WITH THE ADDED BENEFIT OF UVB/UVA BROAD SPECTRUM SPF 30 SUNSCREEN / PA +++. THE OIL FREE FORMULA FORMS AN EVEN, INVISIBLE LAYER THAT ACTS AS A BUFFER TO OUTSIDE ELEMENTS AND EXPERTLY HOLDS FOUNDATION, KEEPING MAKEUP FRESH AND COLOR-TRUE FOR HOURS. VISIBLY SKIN SMOOTHING, NON-CHALKY AND VITAMIN ENRICHED. PERFECT FOR ALL SKIN TYPES, EVEN SENSITIVE.

laura mercier  DIST. GURWITCH PRODUCTS, L.L.C. PO BOX 7568, NEW YORK, NY 10150 MADE IN USA lauramercier.com 001  FOUNDATION PRIMER - PROTECT FPO 7 36150 11726 7

Directions for use: Smooth on Foundation Primer - Protect by gently massaging into the surface of your skin. Can be applied over moisturizer or onto clean skin before Laura Mercier Tinted Moisturizer, Foundation or Concealer. DERMATOLOGIST TESTED. NONCOMEDOGENIC.

FOUNDATION PRIMER - PROTECT FPO 7 36150 12021 2 002

Directions for use: Smooth on Foundation Primer - Protect by gently massaging into the surface of your skin. Can be applied over moisturizer or onto clean skin before Laura Mercier Tinted Moisturizer, Foundation or Concealer.

DERMATOLOGIST TESTED. NONCOMEDOGENIC.

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of rash or irritation appear. If irritation persists, consult a doctor.

foundation primer - protect BROAD SPECTRUM SPF 30 SUNSCREEN / PA+++

laura mercier  1.7 FL.OZ./50 ml

Foundation Primer Broad Spectrum SPF 30 1.7 FL.OZ./50 ml

Tube LabelOuter Carton Label

Foundation Primer Broad Spectrum SPF 30 0.5 FL. OZ. / 15 ml

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Foundation Primer Broad Spectrum SPF 30 2.0ml/0.07 FL.OZ.

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LAURA MERCIER FOUNDATION PRIMER PROTECT  SPF 30
avobenzone, octinoxate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-7005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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:65342-7005-01 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/11/2014
LAURA MERCIER FOUNDATION PRIMER PROTECT  SPF 30
avobenzone, octinoxate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-7003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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:65342-7003-01 in 1 CARTON
115 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/11/2014
LAURA MERCIER FOUNDATION PRIMER PROTECT  SPF 30
avobenzone, octinoxate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-7001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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:65342-7001-51 in 1 CARTON
12 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/11/2014
Labeler - Gurwitch Products, LLC (884875246)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(65342-7005, 65342-7003, 65342-7001)

Revised: 4/2014
Document Id: a9fe4c82-3c58-49de-9016-bf16d1d616c1
Set id: 13c72c14-2261-4523-aa74-ba63200a1281
Version: 4
Effective Time: 20140415
 
Gurwitch Products, LLC