JAFRA SUN PROTECTOR SPF 15- homosalate, oxybenzone, avobenzone and octisalate stick 
Jafra Cosmetics International Inc

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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Sunscreen Active ingredients (SPF 15): Homosalate, Oxybenzone/Benzophenone-3, Butymethoxydibenzoylmethane/Avobenzone, Octisalate/Ethylhexyl Salicylate.

Purpose: Sunscreen

Keep out of reach of children

Discontinue use if irritation/rush occurs.

Warning:  For External use only. For use on children under six months, consult a physician. Avoid contact with eyes.

To use: Apply to lips. Apply protector 20 minutes before exposure. Re-apply frequently to maintain protection, especially after perspiring,swimming, or toweling.

Other ingredients: Castor (Ricinus Communis) Oil, Bis-diglyceryl Polyacrylamide-2, Candellila (Euphorbia Cerifera) Wax, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Polyisobutene, C12-13 Alkyl Lactate, Synthetic Beeswax, PPG-51/SDMI Copolymer. Mica, Silica, Carnauba (Copernica Cerifera) Wax, Tri-C14-15 Alkyl Citrate, Stearalkonium Hectorite, Propylene carbonate, Microcrystaline (cera microcrystallina) Wax, Behenyl Behenate, Mica, Hydrogenated Palm Kernel Glyceride, Hydrogenated Palm Glycerides, Isoeicosane, Isopropylparaben, Isobutylparaben, Butylparaben, Tocopheryl Acetate, Tocopherol, Propylparaben, Lauryl PCA, Soybean (Glycine Soja) Extract, Ceramide III, Allantoin, Pyridoxine, Dicaprylate, Ascorbyl Palmitate, Fragrance/Parfum.

Jafra Sun

15

Protector Stick
SPF 15 UVA/UVB Protection

Barra Protectora
FPS 15 Protecion
Avanzada contra rayos UVA/UVB

4g Net wt. .15 oz




image of carton label






JAFRA SUN  PROTECTOR SPF 15
homosalate,oxybenzone, avobenzone, octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-097
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE5.0 g  in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE2.5 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
CANDELILLA WAX 
ISOPROPYL PALMITATE 
POLYISOBUTYLENE (1300 MW) 
MICA 
SILICON DIOXIDE 
CARNAUBA WAX 
PROPYLENE CARBONATE 
MICROCRYSTALLINE WAX 
BEHENYL BEHENATE 
MICA 
HYDROGENATED PALM GLYCERIDES 
ISOEICOSANE 
ISOPROPYLPARABEN 
ISOBUTYLPARABEN 
BUTYLPARABEN 
.ALPHA.-TOCOPHEROL ACETATE 
TOCOPHEROL 
PROPYLPARABEN 
LAURYL PCA 
SOYBEAN GERM 
CERAMIDE 3 
ALLANTOIN 
ASCORBYL PALMITATE 
Packaging
#Item CodePackage Description
1NDC:68828-097-011 in 1 CARTON
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/15/2012
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture

Revised: 06/2012
Document Id: 6b9974e4-5c43-47b6-b759-3129eacff366
Set id: caa50f71-eeaa-47b0-af66-5dc5d372cbfb
Version: 1
Effective Time: 20120612
 
Jafra Cosmetics International Inc