SUN BROAD SPECTRUM SPF 30 JAFRA- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray 
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.

----------

Sun Spray Sunscreen SPF 30

Active Ingredients      Purpose

Avobenzone 3%        Sunscreen

Homosalate 10%       Sunscreen

Octisalate 5%            Sunscreen

Octocrylene 2.79        Sunscreen

Oxybenzone 6%        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.

keep out of reach of children

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Do not use on damaged or broken skin

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

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

- apply liberally 15 mintues 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 10a.m. - 2 p.m.

      - wear long-sleeve shirts, pants, hats, and sunglasses

Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Bisabolol, Butyrospermum Parkii (Shea Butter) Fruit, Caprylyl Glycol, Cetearyl Alcohol, Cucumis Sativus (cucumber) Fruit Extract, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, DMDM Hydantoin, Fragrance/Parfum, Glycyrrhiza Glabra (Licorice) Extract, Glycerin, Hexylene Glycol, Moringa Oleifera Extract, Octyldodecanol Neopentanoate, Panthenol, Polyester-8, Polysorbate 20, Potassium Sorbate, Sorbitan Oleate, Tilia Cordata Flower Extract, Tocopheryl Acetate, Trienthanolamine, Trisodium EDTA, Vetivera Zinzanoids (Khus Root)  Extract, Water/Aqua, Withania Somnifera (Winter Cherry) Extract

Jafra

Sun spray sunscreen broad spectrum SPF 30

125 ml 4.2 Fl Oz

Carton art

SUN BROAD SPECTRUM SPF 30  JAFRA
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-187
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) OCTOCRYLENE2.79 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LEVOMENOL (UNII: 24WE03BX2T)  
SHEA BUTTER (UNII: K49155WL9Y)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CUCUMBER (UNII: YY7C30VXJT)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
LICORICE (UNII: 61ZBX54883)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MORINGA OLEIFERA BARK (UNII: 1X2218R709)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
CHRYSOPOGON ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z)  
WATER (UNII: 059QF0KO0R)  
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-187-021 in 1 CARTON02/26/201401/01/2021
1NDC:68828-187-01125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/26/201401/01/2021
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-187)

Revised: 1/2021
 
Jafra Cosmetics International Inc