LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types

LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types

Drug Labeling and Warnings

Drug Details

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LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 DAY FACIAL SPF 15 AGAINST NOTICEABLE SIGNS OF AGING ALL SKIN TYPES- avobenzone, octisalate, octocrylene, and oxybenzone lotion 
Ventura International

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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LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types

Drug Facts

Active IngredientsPurpose
AVOBENZONE 3%Sunscreen
OCTISALATE 5%Sunscreen
OCTOCRYLENE 3%Sunscreen
OXYBENZONE 5%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

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor
  • 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.

Other information

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

WATER, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, GLYCERIN, POTASSIUM CETYL PHOSPHATE, ALBIZIA JULIBRISSIN BARK EXTRACT, DIMETHICONE, GLYCERYL STEARATE, PENTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, XANTHAN GUM, C20-22 ALKYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, FRAGRANCE, C20-22 ALCOHOLS, CHLORPHENESIN, HYDROLYZED CERATONIA SILIQUA SEED EXTRACT, SODIUM HYDROXIDE, ACACIA SENEGAL GUM, DISODIUM EDTA, OLIVE OIL AMINOPROPANEDIOL ESTERS, RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, HYDROXYPROPYL CYCLODEXTRIN, PALMITOYL TRIPEPTIDE-38.

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL
33126

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

FORMULATED BY FRENCH DERMATOLOGISTS
SKIN
EXPERTS

LEDERM

DAY LOTION

SUNSCREEN
BROAD SPECTRUM
SPF 15

day facial lotion
SPF 15 against
noticeable signs
of aging
all skin types

50 ml e (1.6 fl.oz.)

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 DAY FACIAL SPF 15 AGAINST NOTICEABLE SIGNS OF AGING ALL SKIN TYPES 
avobenzone, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
C20-22 ALCOHOLS (UNII: O4M0347C6A)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ACACIA (UNII: 5C5403N26O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-119-021 in 1 BOX09/15/2017
1NDC: 14783-119-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/15/2017
Labeler - Ventura International (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-119)

Revised: 9/2017
 
Ventura International


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