SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by VALU MERCHANDISERS, CO, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

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.

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
• 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 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
• children under 6 months of age: Ask a doctor

Other information

• protect the product from excessive heat and direct sun
• avoid long term storage above 40°C (104°F)

Inactive ingredients

alcohol denat., acrylates/octylacrylamide copolymer, glycerin, fragrance, caprylic/capric triglyceride

Adverse reaction

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sport High Performance Sunscreen Continuous Spray UVA/UVB Broad Spectrum SPF 70

Best Choice

100% Guaranteed

www.bestchoicebrand.com

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO

5000 KANSAS AVE

KANSAS CITY, KS 66106

788.000/788AA

principal display panel

Best

Choice

Compare to Coppertone

SPORT

SUNSCREEN

CONTINUOUS SPRAY

BROAD SPECTRUM

SPF 70

UVA/UVB Sunscreen

• Water Resistant (80 minutes)
• Dermatologist Tested
• Sprays At Any Angle

NET WT 6 OZ (170 g)

INGREDIENTS AND APPEARANCE

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-788
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	27.03 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	135.15 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	45.05 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	90.1 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	54.06 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)
glycerin (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-788-30	170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/15/2017

Labeler - VALU MERCHANDISERS, CO (868703513)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(63941-788)