GENTLE HYDRATING DAY CREAM BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate and 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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Active Ingredients Purpose
Avobenzone 2.5% Sunscreen

Octinoxate 7% Sunscreen

Oxtisalate 4% sunscreen

Oxybenzone 1% 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 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 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 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

Water/aqua, Hydroxyethyl Acrylate/sodium Acryloyldimethyltaurate Copolymer, Squalane, Polysorbate 60, Tridecyl Neopentanoate, Aluminum starch Octenylsuccinate, Saccharide Isomerate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Butylene Glycol, Avena Sativa (Oat) Kernal Extract, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Hemidesmus Indicus Extract, Phyllanthus Emblica Extract, Glycyrrhiza, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Panthenol, Tocopheryl Acetate, Dimethicone, Pueraria Lobata Root Extract, Trisodium EDTA, Pentylene Glycol, Hydroxyphenyl propamidobenzoic Acid

image of carton

Gentle Hydrating Day Cream

Broad Spectrum SPF 15


with intellishield


Cont. Net. 50 ml 1.7 Fl Oz. (US)

GENTLE HYDRATING DAY CREAM BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-115
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.5 g  in 100 mL
octinoxate (OCTINOXATE) octinoxate7 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) 
SQUALANE 
POLYSORBATE 60 
TRIDECYL NEOPENTANOATE 
ALUMINUM STARCH OCTENYLSUCCINATE 
SACCHARIDE ISOMERATE 
C13-14 ISOPARAFFIN 
LAURETH-7 
BUTYLENE GLYCOL 
OAT 
PHENOXYETHANOL 
HEXYLENE GLYCOL 
CAPRYLYL GLYCOL 
POTASSIUM SORBATE 
LICORICE 
CHONDRUS CRISPUS 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
DIMETHICONE 
PUERARIA MONTANA VAR. LOBATA ROOT 
EDETATE TRISODIUM 
PENTYLENE GLYCOL 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
Packaging
#Item CodePackage Description
1NDC:68828-115-0150 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/29/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-115)

Revised: 10/2012
Document Id: b85d7f71-8723-4118-82ee-802f8058ec2d
Set id: 0473f576-71f3-4732-a38a-a59cdc78fe27
Version: 1
Effective Time: 20121029
 
JAFRA COSMETICS INTERNATIONAL