Sunscreen (Avobenzone, Homosalate, Octisalate, Oxybenzone) Spray [Family Dollar Services, Inc] -

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) SPRAY [FAMILY DOLLAR SERVICES, INC]
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NDC	55319-787-18
Set ID	fcd2afc0-419b-429e-9b0c-9daf990b62c2
Category	HUMAN OTC DRUG LABEL
Packager	Family Dollar Services, Inc
Generic Name
Product Class
Product Number
Application Number	PART352

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Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Oxybenzone 6%
Purpose

Sunscreen
Use
- 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, Aloe barbadensis leaf extract, fragrance, Cocos nucifera (coconut) oil, mineral oil
SPL UNCLASSIFIED SECTION

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 50.

Distributed by: Family Dollar Services Inc., 10401 Monroe Rd., Matthews, NC 28105, USA
princpal display panel

Tropic

Sun

SPORT

Sunscreen

Spray

BROAD SPECTRUM

SPF 50

compare to

COPPERTONE SPORT

SUNSCREEN

SPF 50

WATER RESISTANT

(80 MINUTES)

UVA/UVB SUNSCREEN

PARABEN FREE

NET WT.2.5 OZ (71 g)

INGREDIENTS AND APPEARANCE

SUNSCREEN
avobenzone, homosalate, octisalate, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55319-787
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	26.49 mg in 1 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	132.45 mg in 1 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	44.15 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	52.98 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT OIL (UNII: Q9L0O73W7L)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55319-787-18	71 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/07/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/07/2017

Labeler - Family Dollar Services, Inc (024472631)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(55319-787)

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Medic

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) SPRAY [FAMILY DOLLAR SERVICES, INC]

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