NATURISSIMA VITAVERDE SUN HIGH PROTECTION SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream 
S.I.P.R.E.S. SRL

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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NATURISSIMA VITAVERDE SUN CREAM HIGH PROTECTION SPF 50

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5.5%

Oxybenzone 5%

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

  • Apply liberally and evenly 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

aqua (water), lavandula angustifolia (lavender) flower water, C12-15 alkyl benzoate, dipropylene glycol, polyurethane-34, dimethicone, glyceryl stearate, PEG-100 stearate, glycerin, caprylyl glycol, bisabolol, tocopheryl acetate, dipotassium glycyrrhizate, aloe barbadensis leaf juice, carica papaya (papaya) fruit extract, algin, cocos nucifera (coconut) oil, avena sativa (oat) kernel extract, acrylates/C10-30 alkyl acrylate crosspolymer, hexylene glycol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, disodium edta, polysorbate 80, carnosine, disodium adenosine triphosphate, sodium hydroxide, citric acid, parfum (fragrance), phenoxyethanol, benzyl alcohol, sodium benzoate, potassium sorbate

Package Labeling:

Label

NATURISSIMA VITAVERDE SUN HIGH PROTECTION SPF 50 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52371-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE55 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LEVOMENOL (UNII: 24WE03BX2T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PAPAYA (UNII: KU94FIY6JB)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OAT (UNII: Z6J799EAJK)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARNOSINE (UNII: 8HO6PVN24W)  
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52371-050-06200 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/04/2018
Labeler - S.I.P.R.E.S. SRL (440712842)

Revised: 3/2018
Document Id: 66a966a1-1fba-4886-e053-2a91aa0a842e
Set id: 9be1ab8f-6223-40d9-b3b3-7a55560c12f3
Version: 2
Effective Time: 20180305
 
S.I.P.R.E.S. SRL