A PERFECT WORLD AGE DEFENSE EYE WITH WHITE TEA BROAD SPECTRUM SPF 20- titanium dioxide and zinc oxide cream

A PERFECT WORLD AGE DEFENSE EYE WITH WHITE TEA BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

A PERFECT WORLD AGE DEFENSE EYE WITH WHITE TEA BROAD SPECTRUM SPF 20 by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., Estee Lauder Companies Inc., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, PADC 1, Northtec LLC, Estee Lauder Cosmetics Ltd., PALC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
titanium dioxide 5.7%	Sunscreen
zinc oxide 3.8%	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 isocetyl stearoyl stearate butylene glycol c12-15 alkyl benzoate cetyl alcohol butyrospermum parkii (shea butter) laureth-4 dimethicone trehalose polyethylene peg-100 stearate cetyl esters camellia sinensis (white tea) leaf extract sigesbeckia orientalis (st. paul's wort) extract vaccinium macrocarpon (cranberry) fruit extract vaccinium angustifolium (blueberry) fruit extract solanum tuberosum (potato) pulp extract opuntia tuna extract lycium chinense (wolfberry) fruit extract eriobotrya japonica (loquat) leaf extract molasses extract\saccharum officinarum\extrait de mélasse betula alba (birch) bark extract passiflora incarnata flower extract lythrum salicaria extract saccharomyces lysate extract phytosphingosine aminopropyl ascorbyl phosphate leontopodium alpinum extract algae extract sodium hyaluronate yeast extract\faex\extrait de levure boswellia serrata extract astrocaryum murumuru seed butter ergothioneine oryzanol hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer lauric acid glycerin squalane tocopheryl acetate isostearic acid caprylyl glycol polyhydroxystearic acid polysorbate 60 sodium pca urea sodium phytate aluminum hydroxide tromethamine hexylene glycol polyquaternium-51 lecithin bht phenoxyethanol mica iron oxides (ci 77491, ci 77492, ci 77499) <iln42825>

Other information

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

PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton

ORIGINS

A PERFECT
WORLD™ SPF 20

Age-Defense Eye Cream
with White Tea
Broad Spectrum
SPF 20

.5 fl. oz./oz. liq./15 ml e

INGREDIENTS AND APPEARANCE

A PERFECT WORLD AGE DEFENSE EYE WITH WHITE TEA BROAD SPECTRUM SPF 20 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	61.56 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	41 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
LAURETH-4 (UNII: 6HQ855798J)
DIMETHICONE (UNII: 92RU3N3Y1O)
TREHALOSE (UNII: B8WCK70T7I)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ESTERS WAX (UNII: D072FFP9GU)
WHITE TEA (UNII: O0M3396E09)
CRANBERRY (UNII: 0MVO31Q3QS)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
POTATO PULP (UNII: 844I2DX0IS)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)
MOLASSES (UNII: LSU3YX0KZO)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
ORYZANOL (UNII: SST9XCL51M)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
LAURIC ACID (UNII: 1160N9NU9U)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOSTEARIC ACID (UNII: X33R8U0062)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
UREA (UNII: 8W8T17847W)
PHYTATE SODIUM (UNII: 88496G1ERL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TROMETHAMINE (UNII: 023C2WHX2V)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
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: 59427-011-01	1 in 1 CARTON	06/01/2017
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-011) , REPACK(59427-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-011)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-011)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59427-011) , REPACK(59427-011)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59427-011) , REPACK(59427-011)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-011)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-011)