SUNSCREEN- avobenzone, homosalate, octisalate, oxybenzone spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Avobenzone 2%, Homosalate 15%, Octisalate 5%, Oxybenzone 4%
Available from:
Valu Merchandiser, Co
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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 on damaged or broken skin rash occurs
Authorization status:
OTC monograph final
Authorization number:
63941-730-30

SUNSCREEN- avobenzone, homosalate, octisalate, oxybenzone spray

Valu Merchandiser, Co

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.

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Best Choice 730.000/730AA

Active ingredients

Avobenzone 2%

Homosalate 15%

Octisalate 5%

Oxybenzone 4%

Purpos e

Sunscreen

Us e

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

claims

May stain or damage some fabrics or surfaces

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sport High

Performance Sunscreen Continuous Spray UVA/UVB Broad Spectrum SPF 30.

Adverse Reaction

Best Choice

100% Guaranteed

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO,

5000 KANSAS AVE

KANSAD CITY, 66106

730.000/730AA

principal display panel

Best

Choice

Compare to Coppertone

SPORT

SUNSCREEN

CONTINUOUS SPRAY

BROAD SPECTRUM

SPF 30

UVA/UVB Sunscreen

Water Resistant (80 minutes

Dermatologist Tested

Sprays At Any Angle

NET WT 6 OZ (170 g)

SUNSCREEN

avobenzone, homosalate, octisalate, oxybenzone spray

Valu Merchandiser, Co

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 41-730

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Avo benzo ne (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

Avo be nz o ne

20 mg in 1 g

Ho mo sa la te (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

Ho mo sa la te

150 mg in 1 g

O ctisa la te (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

O c tisa la te

50 mg in 1 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

40 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ACRYLIC ACID/ISO PHO RO NE DIISO CYANATE/PEG-2 7 CO PO LYMER (UNII: R0 R8 I3X29 J)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 39 41-730 -

170 g in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

12/13/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

12/13/20 17

Labeler -

Valu Merchandiser, Co (868703513)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

79 0 752542

ma nufa c ture (6 39 41-730 )

Revised: 5/2020

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