FRE BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene cream

Fre by

Drug Labeling and Warnings

Fre by is a Otc medication manufactured, distributed, or labeled by Emilia Personal Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzon 3.0%

Homosalate, 8.0%

Octisalate, 4.0%

Octocrylene, 2.0%

PURPOSE

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

INDICATIONS & USAGE

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

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

Keep out of reach of children. If

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

DOSAGE & ADMINISTRATION

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 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

INACTIVE INGREDIENT

Inactive ingredients  water, glycerin, styrene/acrylates copolymer, glyceryl

stearate, PEG-100 stearate, cetearyl alcohol, cetearyl glucoside, caprylyl methicone, dimethicone, trisiloxanane,

argania spinosa kernel oil, ascorbyl glucoside,

phenoxyethanol, ethylhexylglycerin, potassium cetyl

phosphate, hydrogenated palm glyceride, diethylhexyl

2,6-naphthalate, behenyl alcohol, argania spinosa leaf

extract, maltodextrin, panthenol (pro-vitamin B5), butylene

glycol, pentylene glycol, hydroxyphenol propamidobenzoic

acid, polymethyl methacrylate, fragrance, disodium EDTA,

xanthan gum, tocopheryl acetate (vitamin E), bisabolol,

camosine, BHT, retinyl palmitate (vitamin A), chamomilla

recutita (matricaria) flower extract, melissa officinalis leaf

extract, aspalathus linearis (rooibos) leaf extract, tilia

vulgaris (linden blossom) flower extract

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRE  BROAD SPECTRUM
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42421-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.8 g  in 60 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.8 g  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.4 g  in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.2 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
styrene (UNII: 44LJ2U959V)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
ARGAN OIL (UNII: 4V59G5UW9X)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
DOCOSANOL (UNII: 9G1OE216XY)
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHAMOMILE (UNII: FGL3685T2X)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
CARNOSINE (UNII: 8HO6PVN24W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42421-600-60	60 mL in 1 TUBE; Type 0: Not a Combination Product	06/28/2016
2	NDC: 42421-600-20	20 mL in 1 TUBE; Type 0: Not a Combination Product	08/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/28/2016

Labeler - Emilia Personal Care Inc (965445112)