Sport Sunscreen Lotion

Sport Sunscreen Lotion

Drug Labeling and Warnings

Drug Details

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SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
Family Dollar Services, Inc

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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Sport Sunscreen Lotion

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

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)

image description

764.000/764AA

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-764
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE119 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE45.9 mg  in 1 mL
oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) oxybenzone55.08 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-764-2189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2016
2NDC: 55319-764-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/12/2016
Labeler - Family Dollar Services, Inc (024472631)
Registrant - Vi-Jon, Inc (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc088520668manufacture(55319-764)

Revised: 12/2018
 
Family Dollar Services, Inc


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