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

FRE Protect Body Broad Spectrum SPF30 by

Drug Labeling and Warnings

FRE Protect Body Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

FRE PROTECT BODY BROAD SPECTRUM SPF30 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-052-05	150 mL in 1 TUBE; Type 0: Not a Combination Product	05/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/15/2019

Labeler - Emilia Cosmetics Ltd (600076624)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Cosmetics Ltd		600076624	manufacture(43219-052) , label(43219-052)