LOREAL PARIS BRIGHT REVEAL BROAD SPECTRUM SPF 50 DAILY UV SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

LOreal Paris Bright Reveal Broad Spectrum SPF 50 Daily UV Sunscreen by

Drug Labeling and Warnings

LOreal Paris Bright Reveal Broad Spectrum SPF 50 Daily UV Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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, alcohol denat., glycerin, styrene/acrylates copolymer, dimethicone, butyloctyl salicylate, silica, isononyl isononanoate, isopropyl myristate, cetearyl alcohol, calcium aluminum borosilicate, tocopherol, t-butyl alcohol, ascorbyl glucoside, lecithin, sodium stearoyl glutamate, sodium dodecylbenzenesulfonate, phenoxyethanol, phenylethyl resorcinol, adenosine, PEG-8 laurate, PEG-20, trisodium ethylenediamine disuccinate, sclerotium gum, pullulan, ammonium acryloyldimethyltaurate/VP copolymer, xanthan gum , isocetyl stearate, caprylyl glycol, carbomer, cetearyl glucoside, inulin lauryl carbamate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS BRIGHT REVEAL BROAD SPECTRUM SPF 50 DAILY UV SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-996
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
TOCOPHEROL (UNII: R0ZB2556P8)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
ADENOSINE (UNII: K72T3FS567)
PEG-8 LAURATE (UNII: 762O8IWA10)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-996-01	1 in 1 CARTON	05/13/2024
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/13/2024

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(49967-996)