FRE PROTECT BODY BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene cream 
Emilia Cosmetics Ltd

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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FRE Protect Body Broad Spectrum SPF30

Drug Facts

Acitve Ingredients

Avobenzone, 3%

Homosalate, 10%

Octisalate, 5%

Octocrylene, 10%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused 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 Centre right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours.
  • use water resistant sunscreen if swimming or sweating, 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 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 shits, pants, hats and sunglasses.

Other Information

  • protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

water, propanediol, coco-caprylate, diethylhexyl 2,6-naphthalate C12-15 alkyl benzoate, oryza sativa (rice) starch, phenoxyethanol, ethylhexylglycerin, tricontanyl PVP, glycerin, argania spinosa leaf extract, aloe barbadensis leaf juice, polyglyceryl-10 pentastearate, behenyl alcohol, sodium stearoyl lactylate, potassium cetyl phosphate, fragrace, xanthan gum, acrylate/C10-30 alkyl acrylate crosspolymer, allantoin, tocopheryl acetate (vitamin E), argania spinosa kernel oil, sodium phytate, butylene glycol, pentylene glycol, hydroxyphenyl propamidobenzoic acid, panthenol (pro-vitamin B5), sodium hydroxide, argania spinosa sprout cell extract, isomalt, lecithin, sodium benzoate.

Package Labeling:

Label

FRE PROTECT BODY BROAD SPECTRUM SPF30 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-052
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) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
STARCH, RICE (UNII: 4DGK8B7I3S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)  
DOCOSANOL (UNII: 9G1OE216XY)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ARGAN OIL (UNII: 4V59G5UW9X)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ISOMALT (UNII: S870P55O2W)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43219-052-05150 mL in 1 TUBE; Type 0: Not a Combination Product05/15/201901/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/15/201901/30/2022
Labeler - Emilia Cosmetics Ltd (600076624)
Establishment
NameAddressID/FEIBusiness Operations
Emilia Cosmetics Ltd600076624manufacture(43219-052) , label(43219-052)

Revised: 6/2023
 
Emilia Cosmetics Ltd