Big Lots Soundbody Sun Defense Screen Broad Spectrum SPF 70: Package Insert and Label Information

BIG LOTS SOUNDBODY SUN DEFENSE SCREEN BROAD SPECTRUM SPF 70- octocrylene, octisalate, homosalate, avobenzone and oxybenzone lotion
BIG LOTS STORES, INC.

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.

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.5%, Oxybenzone 4.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see ​Directions ​), decreases 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

​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
reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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-sleeved shirts, pants, hats, and sunglasses

Other information

• protect the product in this container from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

Water, Styrene/Acrylates Copolymer, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Silica, Butyloctyl Salicylate, Dimethicone/PEG-10/15 Crosspolymer, Trisiloxane, Cetyl Dimethicone, Beeswax, Ethylhexylglycerin, Sodium Polyacrylate, Xanthan Gum, Ethylhexyl Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Trideceth-6, Disodium EDTA, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Glycol, Chlorphenesin, Fragrance, Propylene Glycol.

Labels

Big Lots Soundbody Sun Defense Screen Lotion Broad Spectrum SPF 70

6.7 FL OZ (198 mL)

NDC 50594-148-27

BIG LOTS SOUNDBODY SUN DEFENSE SCREEN BROAD SPECTRUM SPF 70 avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-148 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 45 mg in 1 mL OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL OXYBENZONE (OXYBENZONE) OXYBENZONE 40 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER DIMETHICONE POTASSIUM CETYL PHOSPHATE BENZYL ALCOHOL BUTYLOCTYL SALICYLATE BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER CAPRYLYL GLYCOL SILICON DIOXIDE ETHYLHEXYLGLYCERIN PROPYLENE GLYCOL TRISILOXANE DOCOSANOL SODIUM POLYACRYLATE (8000 MW) CETYL DIMETHICONE 150 WHITE WAX ETHYLHEXYL STEARATE TRIDECETH-6 GLYCERYL STEARATE/PEG-100 STEARATE XANTHAN GUM BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER EDETATE DISODIUM CHLORPHENESIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50594-148-27 198 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/03/2014

Labeler — BIG LOTS STORES, INC. (017885351)

Revised: 06/2021 BIG LOTS STORES, INC.