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.

----------

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10056-175
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10056-175-40	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2011	03/22/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/13/2011	03/22/2017

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