Big Lots Soundbody SPF 50 Ultra Shield Sunscreen Lotion

Big Lots Soundbody SPF 50 Ultra Shield Sunscreen by

Drug Labeling and Warnings

Big Lots Soundbody SPF 50 Ultra Shield Sunscreen 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 SPF 50 ULTRA SHIELD SUNSCREEN- avobenzone homosalate octisalate octocrylene lotion 
BIG LOTS STORES, INC.

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Big Lots Soundbody SPF 50 Ultra Shield Sunscreen Lotion

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 7.0%

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, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexyl glycerin, sorbitan isostearate, benzyl alcohol, fragrance

Label

BIG LOTS SOUNDBODY SPF 50 ULTRA SHIELD SUNSCREEN 
avobenzone homosalate octisalate octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
POLYETHYLOXAZOLINE (200000 MW) (UNII: I765I75FT2)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-157-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/16/2019	03/04/2022

Labeler - BIG LOTS STORES, INC. (017885351)

Revised: 10/2024

Document Id: 249f4cbc-ddb7-b71d-e063-6394a90a1f53

34390-5

Set id: f1168323-ea29-c121-e053-2995a90aa566

Version: 2

Effective Time: 20241016