Label: BIG LOTS SOUNDBODY SUN DEFENSE SCREEN BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 50594-148-27
- Packager: BIG LOTS STORES, INC.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated June 29, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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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
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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
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INGREDIENTS AND APPEARANCE
BIG LOTS SOUNDBODY SUN DEFENSE SCREEN BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-148 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 45 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:50594-148-27 198 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2014 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)