BIG LOTS SOUNDBODY SPF 70 SUN DEFENSE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Big Lots Soundbody SPF 70 Sun Defense by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 4.0%, 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

FLAMMABLE:

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

DO NOT USE

​Do not use

• ​​on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove. do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120° F.

STOP USE

​Stop use and ask doctor if​

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

​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
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

protect this product from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

alcohol denat., acrylates/octylacrylamide copolymer, octyldodecyl neopentanoate, tocopheryl acetate, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIG LOTS SOUNDBODY SPF 70 SUN DEFENSE 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Product 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)