Your browser does not support JavaScript! NOURIFUSION (AVOBENZONE, OCTINOXATE, OCTISALATE) LOTION [HERBALIFE INTERNATIONAL OF AMERICA INC.]
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NOURIFUSION (avobenzone, octinoxate, octisalate) lotion
[Herbalife International of America Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredients

Avobenzone (2%)

Octinoxate (7%)

Octisalate (3%)

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measure(see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

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-sleeve shirts, pants, hats and sunglasses

Other information

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Water (Aqua), Dimethicone, C12-15 Alkyl Benzoate, Cetyl Phosphate, Cetearyl Alcohol, Panthenol, Tocopheryl Acetate, Tocopherol, Sodium Ascorbate, Retinol, Trifolium Pratense (Clover) Leaf Extract, Calendula Officinalis Flower Extract, Hydrolyzed Enteromorpha Compressa, Yeast Extract, Helianthus Annuus (Sunflower) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Persea Gratisima (Avocado) Oil, Prunus Armeniaca (Apricot) Kernel Oil, Olea Europaea (Olive) Fruit Oil, Wheat Germ Glycerides, Butylene Glycol, Glycerin, Dipropylene Glycol Dibenzoate, Caprylic/Capric Triglyceride, PPG-15 Stearyl Ether Benzoate, Ceteareth-20, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Carbomer, Aminomethyl Propanol, Disodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben, Red 33 (CI 17200).

Distributed by:

Hearbalife International of America, Inc.

800 W. Olympic Blvd. Suite 406

Los Angeles, CA 90015, USA

Herbalife Internation Luxembourg S.a R.L.

L-1610 Luxenbourg

Imported and Distributed in Canada by:

Herbalife of Canada Ltd.

Importe et distribue au Canada par:

Herbalife du Canada Ltee

Calgary, Alberta, Canada T2B 3P1

Made in USA with US and imported ingredients

Fabrique aux Etats-Unis avec des ingredients

americains et importes

2012 Herbalife

Principal Display Panel

HERBALIFE

NouriFusion

sunscreen

broad spectrum SPF 15

moisturizing lotion

with conditioning antioxidant

vitamins A, C and E

normal to dry

normale a seche

ecran solaire

large spectre FPS 15

lotion hydratante

avec vitamines

antioxydantes

revitalisantes A, C et E

DIN No. 02259192

Box Label

Container Label


NOURIFUSION 
avobenzone, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51785-514
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE1.079 g  in 50 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE3.535 g  in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE1.52 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
ALKYL (C12-15) BENZOATE 
CETYL PHOSPHATE 
CETOSTEARYL ALCOHOL 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
TOCOPHEROL 
SODIUM ASCORBATE 
RETINOL 
TRIFOLIUM PRATENSE LEAF 
CALENDULA OFFICINALIS FLOWER 
ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW) 
YEAST 
SUNFLOWER OIL 
WHEAT GERM OIL 
AVOCADO OIL 
APRICOT KERNEL OIL 
OLIVE OIL 
D&C RED NO. 33 
1,3-BUTYLENE GLYCOL 
GLYCERIN 
DIPROPYLENE GLYCOL DIBENZOATE 
MEDIUM-CHAIN TRIGLYCERIDES 
PPG-15 STEARYL ETHER BENZOATE 
POLYOXYL 20 CETOSTEARYL ETHER 
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) 
C13-14 ISOPARAFFIN 
LAURETH-7 
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) 
AMINOMETHYLPROPANOL 
EDETATE DISODIUM 
PHENOXYETHANOL 
METHYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
ISOBUTYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51785-514-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/25/2012
Labeler - Herbalife International of America Inc. (873035968)

Revised: 6/2013
 
Herbalife International of America Inc.

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