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

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 11.7%

Octisalate 4.5%

Octocrylene 4.5%

Oxybenzone 5.4%

Purpose

Sunscreen

Use

• helps prevent sunburn
• if used as directed with other sun protections measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun

Warnings

For external use only

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 use  reqularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especiallyu 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

Inactive ingredients

water, propylene glycol, neopentyl glycol diheptanoate, styrene/acrylates copolymer, benzyl alcohol, tocopherol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, oleth-3, polyamide-8, chlorphenesin, sodium ascorbyl phosphate, fragrance, disodium EDTA

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 Broad Spectrum SPF 50.

Distributed by:

Family Dollar Services Inc.

10401 Monroe Rd., Matthews, NC 28105, USA

Principal Display Panel

Tropic Sun

Sport Sunscreen Lotion

Broad spectrum SPF 50

Compare to Coppertone Sport Sunscreen*

SPF 50

Water resistant (80 minutes)

UVA/UVB sunscreen

Paraben free

3 FL OZ (89 mL)

764.000/764AA

INGREDIENTS AND APPEARANCE

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-764
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	119 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	45.9 mg  in 1 mL
oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	oxybenzone	55.08 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
OLETH-3 (UNII: BQZ26235UC)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-764-21	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2016
2	NDC: 55319-764-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/12/2016

Labeler - Family Dollar Services, Inc (024472631)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(55319-764)