A PERFECT WORLD SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA- 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 Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
avobenzone 3.00%	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; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower water ∙ butyloctyl salicylate ∙ ethyl macadamiate ∙ methyl trimethicone jojoba esters ∙ butylene glycol ∙ lauryl peg-9 polydimethylsiloxyethyl dimethicone ∙ 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 ∙ hordeum vulgare (barley) extract ∙ cholesterol ∙ caffeine ∙ mangifera indica (mango) seed butter ∙ butyrospermum parkii (shea butter) ∙ potassium cetyl phosphate ∙ cetyl alcohol ∙ ethylhexylglycerin ∙ linoleic acid ∙ squalane ∙ sodium hyaluronate ∙ caprylyl glycol ∙ dehydroxanthan gum ∙ silica ∙ ammonium acryloyldimethyltaurate/vp copolymer ∙ citric acid ∙ sodium stearate ∙ sodium dehydroacetate ∙ phenoxyethanol ∙ mica <iln36381>

1 essential oil

Other information

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

SPL UNCLASSIFIED SECTION

©Origins Nat. Res., Dist. NY, NY 10022

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ORIGINS

A Perfect World™ SPF 25
Age-defense moisturizer with White Tea

Broad Spectrum SPF 25

net wt. 1.7 oz./50 ml e

INGREDIENTS AND APPEARANCE

A PERFECT WORLD  SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA
octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 FRUIT (UNII: DQD16J2B5O)
CHAMOMILE (UNII: FGL3685T2X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
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)
BARLEY (UNII: 5PWM7YLI7R)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CAFFEINE (UNII: 3G6A5W338E)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
SHEA BUTTER (UNII: K49155WL9Y)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
SQUALANE (UNII: GW89575KF9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-702-01	1 in 1 CARTON
1	NDC: 59427-702-02	50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2010

Labeler - ORIGINS NATURAL RESOURCES INC (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL(59427-702) , REPACK(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59427-702) , RELABEL(59427-702) , REPACK(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59427-702) , RELABEL(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE(59427-702) , RELABEL(59427-702) , REPACK(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE(59427-702) , REPACK(59427-702) , RELABEL(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE(59427-702) , REPACK(59427-702) , RELABEL(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-702)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(59427-702)