OTC Medication Information: Big Lots Soundbody Sheer Sunscreen Broad Spectrum SPF 70

BIG LOTS SOUNDBODY SHEER SUNSCREEN BROAD SPECTRUM SPF 70- homosalate, octocrylene, octisalate, 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 3.0%

Octocrylene 7.0%

Oxybenzone 6.0%

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 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 of age: 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, acylates/C12-22 alkyl methacrylate copolymer, propylene glycol, xanthan gum, capryl methicone, polysilicone-15, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, beeswax, silica, dipotassium glycyrrhizate, trimethylsiloxysilicate, sodium polyacrylate, ethylhexyl stearate, trideceth-6, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, disodium EDTA, fragrance

Big Lots Soundbody Sheer Sunscreen Lotion Broad Spectrum SPF 70

3.0 fl oz (89 mL)

NDC 50594-075-09

BIG24410
(click image for full-size original)

BIG LOTS SOUNDBODY SHEER SUNSCREEN BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-075
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 70 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 30 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER
EDETATE DISODIUM
TRIDECETH-6
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)
XANTHAN GUM
ETHYLHEXYL STEARATE
CAPRYLYL TRISILOXANE
DIMETHICONE
WATER
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER
SILICON DIOXIDE
POLYSILICONE-15
GLYCERYL STEARATE/PEG-100 STEARATE
SODIUM POLYACRYLATE (8000 MW)
PROPYLENE GLYCOL
GLYCYRRHIZINATE DIPOTASSIUM
WHITE WAX
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
CETYL DIMETHICONE 45
CAPRYLYL GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50594-075-09 89 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/29/2019
Labeler — BIG LOTS STORES, INC. (017885351)

Revised: 06/2021 BIG LOTS STORES, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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