FRUIT OF THE EARTH SPF 4 MOISTURIZING TANNING SUNSCREEN- octinoxate, 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, Inc. SPF 4 Moisturizing Tanning Sunscreen Lotion

Active ingredients

Octinoxate 2.0%, Oxybenzone 0.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn • higher SPF gives more sunburn protection

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 doctor if

  • rash occurs.

​Keep out of reach of children. ​If product is swallowed, get medical help right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

Other information

• protect this product 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, daucus corota sativa (carrot) root extract, arnica montana flower extract, chamomilla recutita (matricaria) flower extract, germanium maculatum extract, cucumis sativus (cucumber) fruit extract, euphrasia officinalis extract, tilia cordata flower extract, althaea officinalis extract, yucca schidigera extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, potassium cetyl phosphate, propylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, hydrated silica, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, triethanolamine, disodium EDTA, fragrance (parfum)

Questions or comment?

Call toll free 1-800-527-7731

Fruit of the Earth, Inc. SPF 4 Moisturizing Tanning Sunscreen Lotion

Representative Image

FRUIT OF THE EARTH  SPF 4 MOISTURIZING TANNING SUNSCREEN
octinoxate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CARROT (UNII: L56Z1JK48B)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CHAMOMILE (UNII: FGL3685T2X)  
CUCUMBER (UNII: YY7C30VXJT)  
EUPHRASIA STRICTA (UNII: C9642I91WL)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-011-0388 mL in 1 TUBE; Type 0: Not a Combination Product05/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/12/200902/05/2018
Labeler - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-011)

Revised: 2/2023
 
Fruit of the Earth, Inc.