BRIGHTER BY NATURE  SPF 35 SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM- homosalate, octisalate, avobenzone, and octocrylene cream 
ORIGINS NATURAL RESOURCES 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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BRIGHTER BY NATURE™
SPF 35 SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM

Drug Facts

Active ingredientsPurpose
avobenzone 3.00%Sunscreen
homosalate 5.00%Sunscreen
octisalate 5.00%Sunscreen
octocrylene 2.70%Sunscreen

Uses

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

Directions

For sunscreen use:

Inactive ingredients

water\aqua\eau • butyloctyl salicylate • methyl trimethicone • jojoba esters • polyester-8 • ethyl macadamiate • butylene glycol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • peg-100 stearate • butyrospermum parkii (shea butter) • glyceryl stearate • citrus aurantifolia (lime) oil1, citrus grandis (grapefruit) peel oil1, cymbopogon schoenanthus oil1, mentha viridis (spearmint) leaf oil1, salvia sclarea (clary) oil1, ormenis multicaulis oil1, pelargonium graveolens flower oil1, lavandula angustifolia (lavender) oil1, thymus vulgaris (thyme) oil1, coriandrum sativum (coriander) fruit oil1, citral, geraniol, linalool, citronellol, limonene • gentiana lutea (gentian) root extract • hordeum vulgare (barley) extract\extrait d'orge • paeonia albiflora (peony) root extract • sanguisorba officinalis (burnet) root extract • cucumis sativus (cucumber) fruit extract • perilla ocymoides leaf extract • pyrus malus (apple) fruit extract • hydrolyzed rice bran extract • scutellaria baicalensis root extract • triticum vulgare (wheat) germ extract • polygonum tinctorium leaf/stem extract • curcuma longa (turmeric) root extract • palmaria palmata extract • trametes versicolor extract • micrococcus lysate • mangifera indica (mango) seed butter • silica • potassium cetyl phosphate • cetyl alcohol • ethylhexylglycerin • arginine • ascorbyl glucoside • caffeine • lecithin • phytosterols • salicylic acid • cholesterol • behenyl alcohol • tocotrienols • linoleic acid • sodium hyaluronate • squalane • magnesium ascorbyl phosphate • elaeis guineensis (palm) oil • squalene • phospholipids • ammonium acryloyldimethyltaurate/vp copolymer • caprylyl glycol • tocopheryl acetate • glycyrrhetinic acid • dehydroxanthan gum • sodium hydroxide • tocopherol • stearic acid • sodium dehydroacetate • phenoxyethanol • mica <iln38194>


1
essential oil

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ORIGINS

Brighter By Nature SPF 35
Skin tone correcting moisturizer

Broad Spectrum SPF 35
net wt. 1.7 oz./50 ml e

Principal Display Panel - 50 ml Jar Carton
BRIGHTER BY NATURE   SPF 35 SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM
homosalate, octisalate, avobenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.0498 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0498 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.02988 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.02689 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
butyloctyl salicylate (UNII: 2EH13UN8D3)  
methyl trimethicone (UNII: S73ZQI0GXM)  
ethyl macadamiate (UNII: ANA2NCS6V1)  
butylene glycol (UNII: 3XUS85K0RA)  
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)  
peg-100 stearate (UNII: YD01N1999R)  
shea butter (UNII: K49155WL9Y)  
glyceryl monostearate (UNII: 230OU9XXE4)  
lime oil (UNII: UZH29XGA8G)  
citrus maxima fruit rind oil (UNII: 8U3877WD44)  
cymbopogon schoenanthus oil (UNII: XE7K568ILO)  
spearmint oil (UNII: C3M81465G5)  
clary sage oil (UNII: 87L0D4U3M0)  
pelargonium graveolens flower oil (UNII: 3K0J1S7QGC)  
lavender oil (UNII: ZBP1YXW0H8)  
thyme oil (UNII: 2UK410MY6B)  
coriander oil (UNII: 7626GC95E5)  
citral (UNII: T7EU0O9VPP)  
geraniol (UNII: L837108USY)  
linalool, (+/-)- (UNII: D81QY6I88E)  
.beta.-citronellol, (r)- (UNII: P01OUT964K)  
gentiana lutea root (UNII: S72O3284MS)  
paeonia lactiflora root (UNII: 3Z3866YW6P)  
sanguisorba officinalis root (UNII: 4NYV2HT01X)  
cucumber (UNII: YY7C30VXJT)  
perilla frutescens top (UNII: T4L5881Y68)  
apple (UNII: B423VGH5S9)  
scutellaria baicalensis root (UNII: 7J95K7ID2S)  
wheat germ (UNII: YR3G369F5A)  
persicaria tinctoria top (UNII: 4D6LH3E17E)  
turmeric (UNII: 856YO1Z64F)  
dulse (UNII: 7832HOY4ZQ)  
mangifera indica seed butter (UNII: 4OXD9M35X2)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
cetyl alcohol (UNII: 936JST6JCN)  
ethylhexylglycerin (UNII: 147D247K3P)  
arginine (UNII: 94ZLA3W45F)  
ascorbyl glucoside (UNII: 2V52R0NHXW)  
caffeine (UNII: 3G6A5W338E)  
salicylic acid (UNII: O414PZ4LPZ)  
cholesterol (UNII: 97C5T2UQ7J)  
docosanol (UNII: 9G1OE216XY)  
tocotrienols (UNII: KP2MW85SSQ)  
linoleic acid (UNII: 9KJL21T0QJ)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
squalane (UNII: GW89575KF9)  
magnesium ascorbyl phosphate (UNII: 0R822556M5)  
palm oil (UNII: 5QUO05548Z)  
squalene (UNII: 7QWM220FJH)  
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)  
caprylyl glycol (UNII: 00YIU5438U)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
enoxolone (UNII: P540XA09DR)  
sodium hydroxide (UNII: 55X04QC32I)  
tocopherol (UNII: R0ZB2556P8)  
stearic acid (UNII: 4ELV7Z65AP)  
sodium dehydroacetate (UNII: 8W46YN971G)  
phenoxyethanol (UNII: HIE492ZZ3T)  
mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59427-008-011 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/2010
Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(59427-008) , REPACK(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59427-008) , RELABEL(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(59427-008)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(59427-008) , RELABEL(59427-008)

Revised: 4/2013
Document Id: 84eec122-cf3a-41b0-ac2b-97629942a991
Set id: 348dbace-289c-459c-aeda-717ed3773e8d
Version: 1
Effective Time: 20130410
 
ORIGINS NATURAL RESOURCES INC.