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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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

For external use only

FLAMMABLE UNTIL DRY.

Do not use near fire, flame, or heat.

on damaged or broken skin

keep out of eyes. Rinse with water to remove.

rash occurs

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

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

Principle Display Panel

LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE150 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-099-011 in 1 CARTON09/30/2022
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/30/2022
Labeler - Beauty Manufacturing Solutions Corp. (783200723)
Registrant - Beauty Manufacturing Solutions Corp. (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723manufacture(11090-099)

Revised: 12/2022
Document Id: ef2c1165-5555-1cce-e053-2a95a90a0f45
Set id: ef2c1165-5554-1cce-e053-2a95a90a0f45
Version: 1
Effective Time: 20221206
 
Beauty Manufacturing Solutions Corp.