LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene gel

LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

PURPOSE

Avobenzone 3%-Sunscreen

Homosalate 15%-Sunscreen

Octisalate 5%-Sunscreen

Octocrylene 10%-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 UNTIL DRY.

Do not use near fire, flame, or heat.

DO NOT USE

on damaged or broken skin

WHEN USING

keep out of eyes. Rinse with water to remove.

STOP USE

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
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 INGREDIENT

water, alcohol denat.,glycerin, styrene/acrylates copolymer dimethicone, butyloctyl salicylate,silica, Isononyl Isononanoate,Isopropyl Myristate, Cetearyl Alcohol, Calcium Aluminum Borosilicate,Tocopherol,Adenosine,Phenyl Resorcinol,Trisodium Ethylenediamine Disuccinate,Ascorbyl Glucoside,isocetyl stearate,ammonium acryloyldimethyltaurate/vp copolymer,caprylyl glycol,carbomer,cetearyl glucoside, inulin lauryl carbamate,Lecithin,PEG-20,PEG-8 laurate,pullulan,sclerotium gum,sodium dodecylbenzenesulfonate, Sodium Stearoyl Glutamate,t-Butyl Alcohol,Xanthan Gum,Phenoxyethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-099
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	150 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
ADENOSINE (UNII: K72T3FS567)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)
ISOCETYL ISOSTEARATE (UNII: UQP66X2A3X)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
XANTHAN GUM (UNII: TTV12P4NEE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-099-01	1 in 1 CARTON	09/30/2022
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 not final	part352	09/30/2022

Labeler - Beauty Manufacturing Solutions Corp. (783200723)

Registrant - Beauty Manufacturing Solutions Corp. (783200723)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(11090-099)