Label: BIG LOTS SOUNDBODY SPF 70 SUN DEFENSE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray
- NDC Code(s): 50594-151-19
- 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 March 27, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
• apply liberally 15 minutes before sun exposure
• hold can 4-6 inches away from body, spray evenly to ensure complete coverage
• do not spray into face. Spray into hand and apply to face.
• use in well ventilated, but not windy areas
• 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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIG LOTS SOUNDBODY SPF 70 SUN DEFENSE
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 300 mg in 10 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 1500 mg in 10 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 500 mg in 10 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 400 mg in 10 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 600 mg in 10 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50594-151-19 184 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/14/2019 Labeler - BIG LOTS STORES, INC. (017885351)