FRUIT OF THE EARTH SPF 50 KIDS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray 
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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Spa Cology Kids Sunscreen Broad Spectrum 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 caused by the sun

Warnings

For external use only

FLAMMABLE

Do not use

on damaged or broken skin

When using this product

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Alcohol denat. (73.2% v/v), acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidene malonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride

Other information

SP29031D

FRUIT OF THE EARTH  SPF 50 KIDS SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
TOCOPHEROL (UNII: R0ZB2556P8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-208-37156 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 not finalpart35212/04/2014
Labeler - Fruit Of The Earth, Inc. (079559467)

Revised: 1/2022
Document Id: d61f70ec-2e8c-34a0-e053-2a95a90a325e
Set id: 6b402812-36aa-7473-e053-2991aa0af009
Version: 2
Effective Time: 20220121
 
Fruit Of The Earth, Inc.