HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate and oxybenzone jelly 
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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Active Ingredients Purpose

Avobenzone 3% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Oxybenzone 2% 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. If product is swallowed, get medical help or contact a Poison Control Cneter right away.

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.

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 sunscreen measures including:

limit time in the sun, especially from 10a.m.- 2 p.m.

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

Inactive

Water/Aqua, Polyglyceryl-3 Methylglucose Distearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glyceryl Stearate, Glycerin, Panthenol, Tocopheryl Acetate, Withania Somnifera (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Fragrance/Parfum, Ethylhexyglycerin, Methylisothiazolinone, Royal Jelly, Helianthus Annuus (Sunflower) Sprout Extract, Lecithin, Hydrolyzed Myrtus Communis Leaf Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA

carton front

carton back

Jafra

Royal Jelly

with/con

Cellspan Complex

Hand Complex Broad Spectrum SPF 15

Cont. Net. 75 ml 2.5 fl oz (US)

HAND COMPLEX BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octinoxate, octisalate, oxybenzone jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-124
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 75 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 75 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 75 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 75 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYACRYLAMIDE (10000 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
GLYCERYL MONOSTEARATE 
GLYCERIN 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
ETHYLHEXYLGLYCERIN 
METHYLISOTHIAZOLINONE 
ROYAL JELLY 
HELIANTHUS ANNUUS SPROUT 
EGG PHOSPHOLIPIDS 
PEG-4 LAURATE 
IODOPROPYNYL BUTYLCARBAMATE 
EDETATE TRISODIUM 
Packaging
#Item CodePackage Description
1NDC:68828-124-021 in 1 CARTON
1NDC:68828-124-0175 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/13/2013
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-124)

Revised: 02/2013
 
JAFRA COSMETICS INTERNATIONAL