Jafra Sun Body Protector Sunscreen Broad Spectrum SPF 50+

Sun Body Protector Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Sun Body Protector Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUN BODY PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50- 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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Jafra Sun Body Protector Sunscreen Broad Spectrum SPF 50+

Active Ingredient(s)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Oxybenzone 5%

Purpose

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 caused by the sun.

Warnings

For external use only
Do not useon damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove.
Stop use and ask a doctorif rash occurs

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

Directions

  • apply liberally 15 minutes before sun 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 sunglasses

Inactive Ingredients

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, Glycyrrhiza Glabra (Licorice) Extract, Lauroyl Lysine, Methylisothiazolinone, Mica, Moringa Oleifera Extract, Panthenol, PEG-100 Stearate, Styrene/Acrylates Copolymer, Silica, Tocopheryl Acetate, Vetiveria Zizanoides (Khus Root) Extract, Water/Aqua, Withania Somnifera (Winter Cherry) Extract

Other information

protect this product from excessive heat and direct sun

Product label

image description

SUN BODY PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene,oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68828-751
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 COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
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)  
LICORICE (UNII: 61ZBX54883)  
LAUROYL LYSINE (UNII: 113171Q70B)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MICA (UNII: V8A1AW0880)  
MORINGA OLEIFERA BARK (UNII: 1X2218R709)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-100 STEARATE (UNII: YD01N1999R)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHRYSOPOGON ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z)  
WATER (UNII: 059QF0KO0R)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68828-751-011 in 1 CARTON02/01/2023
1125 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/11/202202/01/2023
Labeler - Jafra Cosmetics International (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-751)

Revised: 7/2023