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

BRIGHTER BY NATURE by

Drug Labeling and Warnings

BRIGHTER BY NATURE by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients Purpose

avobenzone 3.00% Sunscreen

homosalate 5.00% Sunscreen

octisalate 5.00% Sunscreen

octocrylene 2.70% 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

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:
- apply generously and evenly 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
- 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 10am – 2pm
  - wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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

Active ingredients	Purpose
avobenzone 3.00%	Sunscreen
homosalate 5.00%	Sunscreen
octisalate 5.00%	Sunscreen
octocrylene 2.70%	Sunscreen

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

INGREDIENTS AND APPEARANCE

BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM
homosalate, octisalate, avobenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.0498 g in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0498 g in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.02988 g in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02689 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC: 59427-008-01	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	10/01/2010

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Name	Address	ID/FEI	Business Operations
Establishment
ELGC K.K.		712808195	RELABEL(59427-008) , REPACK(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59427-008) , RELABEL(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
NORTEC KEYSTONE		943871157	MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC BRISTOL		959338336	MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC KEYSTONE		949264774	MANUFACTURE(59427-008) , RELABEL(59427-008) , REPACK(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
Aveda Corporation		071352058	MANUFACTURE(59427-008)

Name	Address	ID/FEI	Business Operations
Establishment
Pennsylvania Logistics Center		078364654	REPACK(59427-008) , RELABEL(59427-008)

Trademark Results [BRIGHTER BY NATURE]

Mark Image Registration \| Serial	Company Trademark Application Date
BRIGHTER BY NATURE 88895688 not registered Live/Pending	Origins Natural Resources Inc. 2020-04-30
BRIGHTER BY NATURE 77438718 3686937 Live/Registered	Origins Natural Resources, Inc. 2008-04-03