BALANCING SPF 15 JAFRA- avobenzone, octinoxate, octisalate and oxybenzone lotion 
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% Suncreen

Octinoxate 7% Sunscreen

Octisalate 4% 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 swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

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 risk of skin cancer and early skin aging. To decrease this risk, regulalrly 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. to 2 p.m.

Wear long sleeve shirts, pants, hats, and sunglasses

water/Aqua, Tiribehenin PEG-20 Esters, Dimethicone, Dimethicone crosspolymer, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Centella Asiatica Extract, Withania Somnifera Extract, Butylene Glycol, Glyceryl Stearate, Bis-Diglyceryl Polyacyladipate, Iris Florentina Root Extract, Retinyl Palmitate, Zinc Sulfate, Alcohol, Propylene Glycol, Biosaccharide Gum-1, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Xylitol, Xylitan, Xylityl polyglucoside, Butyrospermum Parkii (Shea Butter) Fruit, Acrylates Copolymer, Cyclomethicone, Laminaria Saccharina Extract, Extract, Silanediol Salicylate, Chondrus Chrispus (Carrageenan) Extract, Biosaccharide Gum-4, Triethanolamine, Panthenol, Tocopheryl Carbomer, Xanthan Gum, Fragrance/Parfum, Trisodium EDTA, Yellow 6/CI 15985, Red 33/CI 17200, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic acid, Zingiber Officinale (Ginger) Extract, Bisabolol

Jafra

image of carton

Balance Dynamics


Balancing Lotion

Broad Spectrum SPF 15

with Intellishield


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

BALANCING SPF 15  JAFRA
avobenzone, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-113
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) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
TRIBEHENIN PEG-20 ESTERS 
DIMETHICONE 
CENTELLA ASIATICA 
BUTYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
IRIS GERMANICA VAR. FLORENTINA ROOT 
VITAMIN A PALMITATE 
ZINC SULFATE 
ALCOHOL 
PROPYLENE GLYCOL 
BIOSACCHARIDE GUM-1 
PHENOXYETHANOL 
HEXYLENE GLYCOL 
CAPRYLYL GLYCOL 
POTASSIUM SORBATE 
XYLITOL 
XYLITAN 
GLYCERIN 
SHEA BUTTER 
SHEANUT OIL 
CYCLOMETHICONE 
SACCHARINA LATISSIMA 
SILANEDIOL SALICYLATE 
CHONDRUS CRISPUS 
TROLAMINE 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
CARBOMER 934 
XANTHAN GUM 
EDETATE TRISODIUM 
FD&C YELLOW NO. 6 
D&C RED NO. 33 
PENTYLENE GLYCOL 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
GINGER 
LEVOMENOL 
Packaging
#Item CodePackage Description
1NDC:68828-113-021 in 1 CARTON
1NDC:68828-113-0150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/24/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-113)

Revised: 10/2012
 
JAFRA COSMETICS INTERNATIONAL