A PERFECT WORLD SPF 35 UV BROAD SPECTRUM FACE PROTECTOR- homosalate, octisalate, avobenzone, octocrylene lotion

A PERFECT WORLD by

Drug Labeling and Warnings

A PERFECT WORLD 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 Inc., 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; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower water butyloctyl salicylate methyl trimethicone jojoba esters polyester-8 ethyl macadamiate lauryl peg-9 polydimethylsiloxyethyl dimethicone butylene glycol peg-100 stearate glyceryl stearate citrus aurantium bergamia (bergamot) fruit oil1, citrus medica limonum (lemon) peel oil1, citrus aurantium dulcis (orange) oil1, cinnamomum camphora (camphor) bark oil1, mentha viridis (spearmint) leaf oil1, magnolia acuminata flower extract, iris pallida (orris) root extract, rosa damascena (rose) extract, citral, linalool, limonene camellia sinensis (white tea) leaf extract pinus pinaster bark/bud extract arabidopsis thaliana extract ascorbyl tocopheryl maleate oryzanol ergothioneine triticum vulgare (wheat) germ extract laminaria saccharina extract mangifera indica (mango) seed butter butyrospermum parkii (shea butter) potassium cetyl phosphate caffeine cholesterol linoleic acid hordeum vulgare (barley) extract\extrait d'orge cetyl alcohol ethylhexylglycerin trioctyldodecyl citrate lecithin squalane dehydroxanthan gum caprylyl glycol sodium hyaluronate ammonium acryloyldimethyltaurate/vp copolymer silica sodium stearate citric acid sodium dehydroacetate phenoxyethanol mica iron oxides (ci 77491, ci 77492, ci 77499) <iln36397>

1 essential oil

Other information

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

SPL UNCLASSIFIED SECTION

Dist.
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

ORIGINS

A Perfect World™
SPF 35
UV Face protector
with White Tea

Broad Spectrum SPF 35
1.4 fl. oz./oz. liq./40 ml e

INGREDIENTS AND APPEARANCE

A PERFECT WORLD   SPF 35 UV BROAD SPECTRUM FACE PROTECTOR
homosalate, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-706
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
citrus aurantium flower oil (UNII: D4BGE91OXH)
chamaemelum nobile flower oil (UNII: UB27587839)
butyloctyl salicylate (UNII: 2EH13UN8D3)
methyl trimethicone (UNII: S73ZQI0GXM)
ethyl macadamiate (UNII: ANA2NCS6V1)
butylene glycol (UNII: 3XUS85K0RA)
peg-100 stearate (UNII: YD01N1999R)
glyceryl monostearate (UNII: 230OU9XXE4)
bergamot oil (UNII: 39W1PKE3JI)
lemon oil (UNII: I9GRO824LL)
orange oil (UNII: AKN3KSD11B)
camphor oil (UNII: 75IZZ8Y727)
spearmint oil (UNII: C3M81465G5)
magnolia acuminata flower (UNII: 8LCB7ZW9UL)
iris pallida root (UNII: LVV57EM5OG)
rosa damascena flower (UNII: JWB78P295A)
citral (UNII: T7EU0O9VPP)
linalool, (+/-)- (UNII: D81QY6I88E)
maritime pine (UNII: 50JZ5Z98QY)
gamma oryzanol (UNII: SST9XCL51M)
ergothioneine (UNII: BDZ3DQM98W)
wheat germ (UNII: YR3G369F5A)
saccharina latissima thallus (UNII: 68CMP2MB55)
mangifera indica seed butter (UNII: 4OXD9M35X2)
shea butter (UNII: K49155WL9Y)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
caffeine (UNII: 3G6A5W338E)
cholesterol (UNII: 97C5T2UQ7J)
linoleic acid (UNII: 9KJL21T0QJ)
cetyl alcohol (UNII: 936JST6JCN)
ethylhexylglycerin (UNII: 147D247K3P)
squalane (UNII: GW89575KF9)
caprylyl glycol (UNII: 00YIU5438U)
hyaluronate sodium (UNII: YSE9PPT4TH)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
silicon dioxide (UNII: ETJ7Z6XBU4)
sodium stearate (UNII: QU7E2XA9TG)
citric acid monohydrate (UNII: 2968PHW8QP)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-706-01	1 in 1 CARTON
1	NDC: 59427-706-02	40 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

Labeler - ORIGINS NATURAL RESOURCES INC (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(59427-706) , REPACK(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59427-706) , RELABEL(59427-706) , REPACK(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59427-706) , RELABEL(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(59427-706) , RELABEL(59427-706) , REPACK(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(59427-706) , RELABEL(59427-706) , REPACK(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(59427-706) , RELABEL(59427-706) , REPACK(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(59427-706)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(59427-706) , RELABEL(59427-706)