FRUIT OF THE EARTH SPORT SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion 
Fruit of the Earth, 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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Fruit of the Earth Sport SPF 50 Lotion

Active ingredients

Avobenzone 2.0%, Homosalate 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5%, Oxybenzone 5.0%

Purpose

Sunscreen

Uses

Warnings

​For external use only

​Do not use

​When using this product

​Stop use and ask doctor if​

​Keep out of reach of children. ​

If product is swallowed, get medical help 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 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

• children under 6 months: Ask a doctor

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 (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, aloe barbadensis leaf juice, anthemis nobilis flower extract, citrus limon (lemon) peel extract, geranium maculatum extract, calendula officinalis flower extract, salvia officinalis (sage) leaf extract, arctium lappa root extract, melissa officinalis leaf extract, juglans nigra (black walnut) leaf extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, propylene glycol, potassium cetyl phosphate, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, hydrated silica, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)

11350A

13350A

18350EF

FRUIT OF THE EARTH  SPORT SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
JUGLANS NIGRA LEAF (UNII: I2OQ2W1NI2)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
LEMON PEEL (UNII: 72O054U628)  
SAGE (UNII: 065C5D077J)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-350-1630 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2016
2NDC:62217-350-0988 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2016
3NDC:62217-350-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/20/2016
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c80cb090-b903-ac0d-e053-2995a90a1b45
Set id: 4b431c97-a981-6bf2-e054-00144ff8d46c
Version: 4
Effective Time: 20210726
 
Fruit of the Earth, Inc.