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Body Essentials Hand and Body Moisturizing Formula SPF 8

Dosage form: lotion
Ingredients: OCTINOXATE 70mg in 1mL, OXYBENZONE 30mg in 1mL
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

Drug Facts

Active Ingredient

Octinoxate 7.0%,

Oxybenzone 3.0%

Purpose

Sunscreen

Uses
  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

on broken or damaged skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

   if rash occurs.

Keep out of reach of children.

If product is 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

Other information
  • protect this product from excessive heat and direct sun

Inactive Ingredients:

Water, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Pentaerythrityl Tetraisostearate, Cetyl Alcohol, Sorbitan Stearate, Avena Sativa (Oat) Kernel Protein, Panthenol, Dimethicone, Fragrance, Tocopheryl Acetate, Triethanolamine, Carbomer, Disodium EDTA, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben.

Package Labeling:

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) OCTINOXATE70 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
POLYSORBATE 60 
PENTAERYTHRITYL TETRAISOSTEARATE 
CETYL ALCOHOL 
SORBITAN MONOSTEARATE 
OAT 
PANTHENOL 
DIMETHICONE 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
CARBOXYPOLYMETHYLENE 
EDETATE DISODIUM ANHYDROUS 
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: 12/2017
 
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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