A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA- avobenzone, homosalate, octinoxate, octisalate, and octocrylene cream

A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA by

Drug Labeling and Warnings

A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Northtec LLC, PADC 1, Len-Ron Manufacturing Division of Aramis Inc., Whitman Laboratories Ltd., Estee Lauder N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients Purpose

avobenzone 3.0% Sunscreen

homosalate 8.0% Sunscreen

octinoxate 7.5% Sunscreen

octisalate 4.5% Sunscreen

octocrylene 5.0% 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 butylene glycol glycerin ammonium acryloyldimethyltaurate/vp copolymer polyethylene citrus aurantium bergamia (bergamot) fruit oil1, citrus limon (lemon) peel oil1, citrus aurantium dulcis (orange) oil1, cinnamomum camphora (camphor) bark oil1, mentha viridis (spearmint) leaf oil1, magnolia acuminata flower extract, iris pallida root extract, rosa damascena extract, citral, linalool, limonene cetyl alcohol glyceryl stearate peg-100 stearate peg-6 vaccinium angustifolium (blueberry) fruit extract vaccinium macrocarpon (cranberry) fruit extract solanum tuberosum (potato) pulp extract lycium chinense (wolfberry) fruit extract eriobotrya japonica (loquat) leaf extract passiflora incarnata flower extract leontopodium alpinum extract betula alba (birch) bark extract camellia sinensis (white tea) leaf extract boswellia serrata extract sigesbeckia orientalis (st. paul's wort) extract thermus thermophillus ferment hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract saccharomyces lysate extract lythrum salicaria extract yeast extract\faex\extrait de levure algae extract oryzanol squalane ethylhexylglycerin trehalose steareth-21 ergothioneine sodium hyaluronate vp/eicosene copolymer nylon-12 caprylyl glycol sodium pca sodium dehydroacetate tocopheryl acetate urea ascorbyl tocopheryl maleate citric acid polyquaternium-51 hexylene glycol lecithin sodium phytate bht mica phenoxyethanol <iln42821>

1 essential oil

Active ingredients	Purpose
avobenzone 3.0%	Sunscreen
homosalate 8.0%	Sunscreen
octinoxate 7.5%	Sunscreen
octisalate 4.5%	Sunscreen
octocrylene 5.0%	Sunscreen

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ORIGINS

A PERFECT
WORLD™ SPF 40

Age-Defense Moisturizer
with White Tea
Broad Spectrum SPF 40

net wt. 1.7 oz./50 ml e

Principal Display Panel - 50 ml Jar Carton

INGREDIENTS AND APPEARANCE

A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA
avobenzone, homosalate, octinoxate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
CRANBERRY (UNII: 0MVO31Q3QS)
POTATO PULP (UNII: 844I2DX0IS)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
WHITE TEA (UNII: O0M3396E09)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q)
WHEAT GERM (UNII: YR3G369F5A)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ORYZANOL (UNII: SST9XCL51M)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TREHALOSE (UNII: B8WCK70T7I)
STEARETH-21 (UNII: 53J3F32P58)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
NYLON-12 (UNII: 446U8J075B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHYTATE SODIUM (UNII: 88496G1ERL)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 59427-010-01	1 in 1 CARTON	06/01/2017
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	06/01/2017

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-010) , REPACK(59427-010)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-010)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-010)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-010)

Name	Address	ID/FEI	Business Operations
Establishment
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-010)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC INC		943871157	RELABEL(59427-010) , REPACK(59427-010)

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		949264774	RELABEL(59427-010) , REPACK(59427-010)

Name	Address	ID/FEI	Business Operations
Establishment
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-010)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-010)