LOREAL PARIS ADVANCED SUNCARE QUICK DRY SHEER FINISH 30 BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene aerosol, spray

LOreal Paris Advanced Suncare Quick Dry Sheer Finish 30 Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

LOreal Paris Advanced Suncare Quick Dry Sheer Finish 30 Broad Spectrum SPF 30 Sunscreen 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 2.96%

Homosalate 8.78%

Octisalate 4.88%

Octocrylene 5.92%

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 120F

- keep out of reach of children

- use only as directed

- intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

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 as 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:

● shake well before 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

butane, water, dicaprylyl ether, dimethicone, dicaprylyl carbonate, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, methyl methacrylate crosspolymer, nylon-12, cyclohexasiloxane, menthyl lactate, polymethylsilsesquioxane, PEG-8 laurate, isododecane, dodecene, isoeugenol, fragrance, sodium chloride, vitis vinifera (grape) fruit extract, phenoxyethanol, p-anisic acid, chlorphenesin, tocopherol, disodium EDTA, poloxamer 407, propylene carbonate, lauryl PEG/PPG-18/18 methicone, caprylyl glycol, disteardimonium hectorite, poly C10-30 alkyl acrylate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS ADVANCED SUNCARE QUICK DRY SHEER FINISH 30 BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.6 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	87.8 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.8 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	59.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTANE (UNII: 6LV4FOR43R)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
NYLON-12 (UNII: 446U8J075B)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PEG-8 LAURATE (UNII: 762O8IWA10)
ISODODECANE (UNII: A8289P68Y2)
DODECENE (UNII: WYE669F3GR)
ISOEUGENOL (UNII: 5M0MWY797U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
CHLORPHENESIN (UNII: I670DAL4SZ)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-031-01	127 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(49967-031)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc.		024213616	manufacture(49967-031)