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

Laura Mercier Foundation Primer Protect by

Drug Labeling and Warnings

Laura Mercier Foundation Primer Protect by is a Otc medication manufactured, distributed, or labeled by Gurwitch Products, LLC, Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ever y 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 mea sures 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 (+/): 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.

PRINCIPAL DISPLAY PANEL

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

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

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

INGREDIENTS AND APPEARANCE

LAURA MERCIER FOUNDATION PRIMER PROTECT  SPF 30
avobenzone, octinoxate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-7005
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-7005-0	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/11/2014

LAURA MERCIER FOUNDATION PRIMER PROTECT  SPF 30
avobenzone, octinoxate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-7003
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-7003-0	1 in 1 CARTON
1		15 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/11/2014

LAURA MERCIER FOUNDATION PRIMER PROTECT  SPF 30
avobenzone, octinoxate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-7001
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-7001-5	1 in 1 CARTON
1		2 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/11/2014

Labeler - Gurwitch Products, LLC (884875246)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(65342-7005, 65342-7003, 65342-7001)