Body Series Hand and Body Lotion SPF 8 Moisturizing Formula

Body Essentials Hand and Body Moisturizing Formula by

Drug Labeling and Warnings

Body Essentials Hand and Body Moisturizing Formula by is a Otc medication manufactured, distributed, or labeled by Access Business Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BODY ESSENTIALS HAND AND BODY MOISTURIZING FORMULA SPF 8- octinoxate, oxybenzone lotion 
Access Business Group LLC

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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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:

Label

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
OAT (UNII: Z6J799EAJK)  
PANTHENOL (UNII: WV9CM0O67Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10056-175-40400 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/201103/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/201103/22/2017
Labeler - Access Business Group LLC (839830713)

Revised: 11/2019
Document Id: 97686c75-f5d0-cf1b-e053-2995a90a03fb
Set id: 13e8b983-d567-4406-95dd-8c4265a5ffc8
Version: 5
Effective Time: 20191115
 
Access Business Group LLC