LOREAL PARIS ADVANCED SUNCARE INVISIBLE PROTECT SHEER 50 PLUS BROAD SPECTRUM SPF 50 PLUS- avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray

LOreal Paris Advanced Suncare Invisible Protect Sheer 50 Plus Broad Spectrum SPF 50 Plus by

Drug Labeling and Warnings

LOreal Paris Advanced Suncare Invisible Protect Sheer 50 Plus Broad Spectrum SPF 50 Plus by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc., Accra Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Oxybenzone 6%

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

FLAMMABLE

- avoid fire, flame and heat during application and until fully dry

- use only in a ventilated area

- avoid spraying in eyes

- contents under pressure

- do not puncture or incinerate

- do not store at temperatures above 120°F

- keep out of reach of children

- use only as directed

Do not use

on damaged or broken skin

When using this product

- keep out of eyes. Rinse with water to remove.

- keep away from face to avoid breathing it

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:

● spray generously and spread evenly by hand 15 minutes before sun exposure

● hold container 4 to 6 inches from the skin to apply

● do not spray directly into face. Spray on hands then apply to face.

● do not apply in windy conditions

● use in a well-ventilated area

● reapply:

● after 80 minutes of swimming or sweating

● immediately after towel drying

● 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

alcohol denat., C12-15 alkyl benzoate, dicaprylyl carbonate, vitis vinifera (grape) seed oil, tocopherol, acrylates/octylacrylamide copolymer

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS ADVANCED SUNCARE INVISIBLE PROTECT SHEER 50 PLUS BROAD SPECTRUM SPF 50 PLUS 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-334
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GRAPE SEED OIL (UNII: 930MLC8XGG)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-334-01	120 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		960317444	manufacture(49967-334)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc.		024213616	manufacture(49967-334)