Big Lots Soundbody Sun Defense Screen Lotion Broad Spectrum SPF 70

Big Lots Soundbody Sun Defense Screen Broad Spectrum SPF 70 by

Drug Labeling and Warnings

Big Lots Soundbody Sun Defense Screen Broad Spectrum SPF 70 by is a Otc medication manufactured, distributed, or labeled by BIG LOTS STORES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

----------

Big Lots Soundbody Sun Defense Screen Lotion Broad Spectrum SPF 70

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

BIG24407D

BIG LOTS SOUNDBODY SUN DEFENSE SCREEN BROAD SPECTRUM SPF 70 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50594-148
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE45 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
DOCOSANOL (UNII: 9G1OE216XY)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
WHITE WAX (UNII: 7G1J5DA97F)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50594-148-27198 mL in 1 BOTTLE; Type 0: Not a Combination Product10/03/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/03/201404/09/2023
Labeler - BIG LOTS STORES, INC. (017885351)

Revised: 10/2024
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.