DOLLAR GENERAL STUDIO SELECTION SUN SUNSCREEN BROAD SPECTRUM SPF 85 WITH ALOE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Dollar General Studio Selection Sun Sunscreen Broad Spectrum SPF 85 with Aloe by

Drug Labeling and Warnings

Dollar General Studio Selection Sun Sunscreen Broad Spectrum SPF 85 with Aloe by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%, 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. keep away from face to avoid breathing it. do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120° F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

STOP USE

​Stop use and ask doctor if​

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Spray liberally and spread evenly by hand 15 minutes before sun exposure
Hold can 4 to 6 inches away from skin to apply
Do not spray directly into face. Spray into hand then apply to face.
Use in a well-ventilated area

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., isobutane, VA/butyl maleate/isobornyl acrylate copolymer, caprylyl glycol, cyclopentasiloxane, cyclohexasiloxane, fragrance, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, ascorbyl palmitate, methyl dihydroabietate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf juice

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLLAR GENERAL STUDIO SELECTION SUN SUNSCREEN BROAD SPECTRUM SPF 85 WITH ALOE 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOBUTANE (UNII: BXR49TP611)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-008-37	156 g in 1 CAN; Type 0: Not a Combination Product	03/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/08/2018

Labeler - Dolgencorp, LLC (068331990)