Fruit of the Earth SpaCology Sport SPF 50 Continuous Spray

Fruit of the Earth SpaCology Sport SPF 50 by

Drug Labeling and Warnings

Fruit of the Earth SpaCology Sport 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]

FRUIT OF THE EARTH SPACOLOGY SPORT SPF 50- avobenzone, homosalate, octisalate, oxybenzone, octocrylene spray 
Fruit of the Earth, Inc.

----------

Fruit of the Earth SpaCology Sport SPF 50 Continuous Spray

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 5.0%

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

Flammable:

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove. keep away from face to avoid breathing it. do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120°F.

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

  • Spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into hands then apply to face
  • Do not apply in windy conditions
  • Use in a well-ventilated area
  • 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 protectino 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

alcohol denat., acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride

SP29028D

FRUIT OF THE EARTH SPACOLOGY SPORT SPF 50 
avobenzone, homosalate, octisalate, oxybenzone, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62217-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62217-062-37156 g in 1 CAN; Type 0: Not a Combination Product11/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/14/201711/15/2021
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 10/2024
Document Id: 24b3ae1f-12f2-5376-e063-6394a90a4d22
Set id: c78125cf-e766-ad22-e053-2a95a90afda0
Version: 2
Effective Time: 20241017