Label: LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene gel
- NDC Code(s): 11090-099-01
- Packager: Beauty Manufacturing Solutions Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 6, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- FLAMMABLE UNTIL DRY.
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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 gelProduct 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)