Drug Labeling and Warnings

Drug Details [pdf]

DIAMOND WHITE OIL-FREE BRILLIANT SUN PROTECTION- ensulizole, octinoxate, titanium dioxide, zinc oxide cream 
Natura Bisse International SA

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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Active Ingredients                                      Purpose

Ensulizole 3%

Octinoxate 4.8%           }                           Sunscreen    

Titanium Dioxide 6.3%  

Zinc Oxide 8%

Uses

Helps prevent sunburn

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Natura Bisse

Barcelona

DIMAOND

WHITE

OIL-FREE BRILLIANT

SUN PROTECTION

Broad Spectrum SPF 50

PA+++

Crema protectora solar iluminadora

Brightening Sunscreen cream

Creme de protection solaire eclaircissante

Aufhellende Sonnenschutzcreme

Creme de protecao solar com efeito iluminante

Crema schermo solare illuminante

Net Wt. 1.3 oz. e 30 ml

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

Directions

  • apply liberally 15 minutes before skin exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: 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 sun-glasses

Water (Aqua), Cyclopentasiloxane, Dicaprylyl Carbonate, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Arginine, Stearic Acid, Aluminum Hydroxide, Lactobacillus/Punica Granatum Fruit Ferment Extract, Leuconostoc/Radish Root Ferment Filtrate, Bisabolol, Tocopheryl Acetate, Glyceryl Linoleate, Glyceryl Linolenate, Triethoxycaprylylsilane, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Aluminum Stearate, Hexyl Laurate, Polyglyceryl-4 Isostearate, Isononyl Isononanoate, Dimethiconol, Dimethicone Crosspolymer, Stearalkonium Hectorite, Disodium EDTA, Ethylhexylglycerin, Propylene Carbonate, Sodium Chloride, Phenoxyethanol, Fragrance (Parfum), Lavandula Hybrida Oil, Linalool, Coumarin, Amyl Cinnamal, Alumina, Iron Oxides (CI 77491, CI 77492, CI 77499).

Made in Spain By 

NATURA BISSE INT. S. A.

PQUE TECNOL. del VALLES

Cerdanyola - BARCELONA

Other information protect this product from excessive heat and direct sun.

Questions? 1-800-762-8872

ESTE PROUCTO SOLO PUEDE VENDERSE EN ESTABLECIMIENTOS AUTORIZADOS POR NATURA BISSE

THIS PRODUCT CAN BE SOLD ONLY BY AUTHORIZED NATURA BISSE RETAILERS

label image

DIAMOND WHITE OIL-FREE BRILLIANT SUN PROTECTION 
ensulizole, octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63730-396
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 30 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1 g  in 30 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ARGININE (UNII: 94ZLA3W45F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
LEVOMENOL (UNII: 24WE03BX2T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LAVANDIN OIL (UNII: 9RES347CKG)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
COUMARIN (UNII: A4VZ22K1WT)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63730-396-0130 g in 1 BOTTLE; Type 0: Not a Combination Product03/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/08/201706/15/2019
Labeler - Natura Bisse International SA (464431576)
Establishment
NameAddressID/FEIBusiness Operations
Natura Bisse International SA464431576manufacture(63730-396)

Revised: 6/2019