SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream 
JAFRA COSMETICS 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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Royal Jelly - Solar Protection Fluid Broad Spectrum SPF 50

Active Ingredients        Purpose

Avobenzone 3%         Sunscreen

Homosalate 10%        Suncreen

Octisalate 5%            Suncreen

Octocrylene 7%         Sunscreen

Uses

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

Stop use and ask a doctor if rash occurs

Warnings

Directions

Water/Aqual, Styrene/Acrylate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ethylhexylglycerin, Benzyl Alcohol, Bisabolol, Royal Jelly, Cyclopentasiloxane, Acrylates/Dimethicon Copolymer, Cocos Nucifera, Moringa Oleifera, Fragrance/Parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Cichorium Intybus (Chicory) Root Extract, Kappaphycus Alvarezii Extract, Glycerin, Polygonum Aviculare Extract, Sodium Ascorbyl Phosphate, Benzyl Salicylate, Limonene, Hydroxycitronellal, Butylphenyl Methylpropional (Lillial), Linalool

JAFRA

Royal Jelly

Solar Protection Fluid

Broad Spectrum SPF 50

50 ml   1.7 FL OZ (US)

box image

SOLAR PROTECTION FLUID  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-240
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
LAUROYL LYSINE (UNII: 113171Q70B)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
ROYAL JELLY (UNII: L497I37F0C)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
MORINGA OLEIFERA WHOLE (UNII: 5JH60A416W)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALLANTOIN (UNII: 344S277G0Z)  
ARGININE (UNII: 94ZLA3W45F)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CHICORY ROOT (UNII: 090CTY533N)  
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-240-021 in 1 BOX08/10/2015
1NDC:68828-240-0150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68828-240-031 mL in 1 PACKAGE; Type 0: Not a Combination Product02/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/10/2015
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-240)

Revised: 2/2018
Document Id: 884eb727-dd41-4293-badc-55ec8904af1a
Set id: 13ffe33d-d8b4-41d8-94de-9dd243155d90
Version: 4
Effective Time: 20180205
 
JAFRA COSMETICS INTERNATIONAL