SPA COLOGY SPORT SUNSCREEN LOTION SPF 50

FOTE SPORT SUNSCREEN SPF 50 by

Drug Labeling and Warnings

FOTE SPORT SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by FRUIT OF THE EARTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOTE SPORT SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
FRUIT OF THE EARTH, INC.

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SPA COLOGY SPORT SUNSCREEN LOTION SPF 50

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

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 casued 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

  • children under 6 months of age: Ask a doctor

  • 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 a 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

Other information

  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, aluminum starch octenylsuccinate, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

Label

SPA COLOGY SPORT SUNSCREEN LOTION SPF 50

8.0 FL OZ (237mL)

NDC: 62217-052-11

SP29033EF

FOTE SPORT SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62217-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISODODECANE (UNII: A8289P68Y2)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
WHITE WAX (UNII: 7G1J5DA97F)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
DOCOSANOL (UNII: 9G1OE216XY)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62217-052-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/15/201711/14/2021
Labeler - FRUIT OF THE EARTH, INC. (079559467)

Revised: 10/2024
Document Id: 24b39196-e2d3-7a44-e063-6394a90a38d2
Set id: c55ff3be-b58e-e87b-e053-2a95a90af4dd
Version: 2
Effective Time: 20241017