DRY OIL ANTIOXIDANT SUN PROTECTION- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone 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

Avobenzone 3% .................................................................... Sunscreen

Homosalate 10% ................................................................... Sunscreen

Octinoxate 4% ...................................................................... Sunscreen

Octocrylene 10% ................................................................... Sunscreen

Oxybenzone 5% .................................................................... Sunscreen

Uses

helps prevent sunburn

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

Natura Bissé Barcelona

C+C Dry Oil Antioxidant Sun Protection

Broad Spectrum SPF 30

3.5 Fl. Oz. 100 ml

Made in Spain by 

Natura Bisse Int. S.A.

Pque. Tecnol. del Valles

Cerdanyola - Barcelona

Directions

Warnings

Inactive Ingredients

alcohol denat., diisopropyl sebacate, benzotriazolyl dodecyl p-cresol, tocopheryl acetate, glyceryl linoleate, vitis vinifera (grape) seed oil, bisabolol, helianthus annuus (sunflower) seed oil, citrus nobilis (mandarin orange) oil, glyceryl linolenate, daucus carotiva sativa (carrot) seed oil, beta-carotene, 7-dehydrocholesterol, ascorbyl palmitate, acrylates/octylacrylamide copolymer, fragrance, limonene, linalool, amyl cinnamal, geraniol, citral.

label image

DRY OIL ANTIOXIDANT SUN PROTECTION 
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63730-364
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL LINOLEATE (UNII: 4763AXI84L)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
LEVOMENOL (UNII: 24WE03BX2T)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
CITRUS NOBILIS (UNII: 8MFF77J91V)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
DAUCUS CAROTA SUBSP. SATIVUS WHOLE (UNII: F9I9HZH3O3)  
BETA CAROTENE (UNII: 01YAE03M7J)  
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
GERANIOL (UNII: L837108USY)  
CITRAL (UNII: T7EU0O9VPP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63730-364-01100 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/30/2015
Labeler - Natura Bisse International SA (464431576)
Establishment
NameAddressID/FEIBusiness Operations
Natura Bisse International SA464431576manufacture(63730-364)

Revised: 1/2015
Document Id: e08d1d5a-4655-4af5-8a43-205a75f43355
Set id: 0bb64b29-b587-450a-a703-9446e9fc618a
Version: 1
Effective Time: 20150130
 
Natura Bisse International SA