Body Essentials Hand and Body Moisturizing Formula SPF 8

Dosage form: lotion
Ingredients: OCTINOXATE 7.0mL in 100mL, OXYBENZONE 3mL in 100mL
Labeler: Access Business Group LLC
NDC Code: 10056-175

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.

Body Series Hand and Body Lotion SPF 8 Moisturizing Formula

Use Directions

Use as often as needed for skin conditioning. For sun protection, apply liberally and rub in as necessary 15 to 30 minutes before sun exposure and as needed. Reapply after swimming, perspiring heavily or washing.

Active Ingredient

Octinoxate 7.0%, Oxybenzone 3.0%


Use

Helps prevent sunburn

Warnings

Keep out of eyes

Stop use if skin rash or irritation occurs

Keep out of reach of children.

For external use only. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Water/Eau, Glycerin, Polysorbate 60, Pentaerythrityl Tetarisostarate, Glyceryl Starate, PEG-1-- Starate, Cetyl Esters, Sorbitan Starate, Stearamide DEA, Avena Sativa (Oat) Kernel Protein, Panthenol, dimethicone, Cetyl Alcohol, Fragrance/Parfum, Tocopheryl Acetate, Triethanolamine, Carbomer, Disodium EDTA, Propylene Glycol, Diazolidinyl Urea, methylparaben, propylparaben

DIST. BY ACCESS BUSINESS GROUP INTERNATIONAL LLC, ADA,MI 49355

USA

TRADEMARK LICENSED BY ALTICOR, INC.

Amway Canada Corporation, London, ON N5Y 5V6


Body Series

hand and Body lotion SPF 8

Moisturizing Formula

MADE IN USA

400ml

(13.5fl oz)


BODY ESSENTIALS HAND AND BODY MOISTURIZING FORMULA  SPF 8
octinoxate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-175
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLYSORBATE 60 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
CETYL ESTERS WAX 
SORBITAN MONOSTEARATE 
STEARIC DIETHANOLAMIDE 
AVENA SATIVA FLOWERING TOP 
PANTHENOL 
DIMETHICONE 
CETYL ALCOHOL 
ACETATE ION 
TROLAMINE 
EDETATE DISODIUM 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:10056-175-40400 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2011
Labeler - Access Business Group LLC (839830713)

Revised: 04/2011
 
Access Business Group LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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