SUNSCREEN BROAD SPECTRUM SPF 50  JAFRA- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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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Sunscreen SPF 50

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Oxybenzone 5% 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 by the sun

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

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Do not use on on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least ever 2 hours, especially if swimming, sweating, or after toweling

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 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-sleeve shirts, pants, hats, and sunglasses

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Bisabolol, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragrance/parfum, Glyceryl Stearate, Lauroyl Lysine, Methylisothiazolinone, Mica, Silica, Panthenol, PEG-100 Stearate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water/Aqua.

carton back

carton front

Jafra Sun

50+

Sunscreen Cream Broad Spectrum SPF 50+

UVA/UVB Protection

125 ml 4.2 Fl Oz. (US)

SUNSCREEN BROAD SPECTRUM SPF 50   JAFRA
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-165
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) OCTOCRYLENE10 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALLANTOIN (UNII: 344S277G0Z)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
ARGININE (UNII: 94ZLA3W45F)  
DOCOSANOL (UNII: 9G1OE216XY)  
LEVOMENOL (UNII: 24WE03BX2T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAUROYL LYSINE (UNII: 113171Q70B)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-100 STEARATE (UNII: YD01N1999R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-165-021 in 1 CARTON02/19/2013
1NDC:68828-165-01125 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68828-165-041 in 1 CARTON02/19/2013
2NDC:68828-165-03200 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/19/2013
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-165)

Revised: 6/2020
Document Id: a8b44f5e-bd67-80d3-e053-2995a90aa542
Set id: 9bf66460-1835-4135-b4be-016ffdabe9a8
Version: 4
Effective Time: 20200622
 
JAFRA COSMETICS INTERNATIONAL