ORIGINS A PERFECT WORLD AGE DEFENSE TINTED MOISTURIZER SPF 15- octinoxate, octisalate, and avobenzone liquid

Origins by

Drug Labeling and Warnings

Origins 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
octinoxate 7.50%	Sunscreen
octisalate 5.00%	Sunscreen
avobenzone 2.00%	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 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 dimethicone caprylic/capric/myristic/stearic triglyceride butylene glycol cyclopentasiloxane steareth-2 cetyl ricinoleate di-c12-15 alkyl fumarate polysilicone-11 pentylene glycol steareth-21 coffea arabica (coffee) seed extract triticum vulgare (wheat) germ extract laminaria ochroleuca extract hordeum vulgare (barley) extract\extrait d'orge camellia sinensis (white tea) leaf extract polyethylene hydrogenated lecithin stearyl alcohol polyaminopropyl biguanide linoleic acid cholesterol dimethicone copolyol squalane caffeine sodium pca urea caprylic/capric triglyceride hexylene glycol sodium hyaluronate pantethine polyquaternium-51 sodium hydroxide trehalose oryzanol ascorbyl tocopheryl maleate tromethamine glycerin peg-9 dimethicone behenyl alcohol pvp/hexadecene copolymer carbomer caprylyl glycol fragrance disodium edta linalool limonene citral sorbic acid phenoxyethanol potassium sorbate chlorphenesin [+/- titanium dioxide (ci 77891) iron oxides (ci 77491, ci 77492, ci 77499) bismuth oxychloride (ci 77163) ferric ammonium ferrocyanide (ci 77510) mica red 7 lake (ci 15850)] <iln38491>

Other information

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

ORIGINS

A Perfect World™
SPF 15

Age-defense
tinted moisturizer
with White Tea

Broad Spectrum SPF 15

1.7 fl. oz./50 ml e

INGREDIENTS AND APPEARANCE

ORIGINS   A PERFECT WORLD AGE DEFENSE TINTED MOISTURIZER SPF 15
octinoxate, octisalate, and avobenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	7.5 mL  in 100 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	5 mL  in 100 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
cyclomethicone 5 (UNII: 0THT5PCI0R)
steareth-2 (UNII: V56DFE46J5)
cetyl ricinoleate (UNII: 1P677500YD)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
pentylene glycol (UNII: 50C1307PZG)
steareth-21 (UNII: 53J3F32P58)
arabica coffee bean (UNII: 3SW678MX72)
wheat germ (UNII: YR3G369F5A)
laminaria ochroleuca (UNII: 4R2124HE76)
high density polyethylene (UNII: UG00KM4WR7)
stearyl alcohol (UNII: 2KR89I4H1Y)
polyaminopropyl biguanide (UNII: 322U039GMF)
linoleic acid (UNII: 9KJL21T0QJ)
cholesterol (UNII: 97C5T2UQ7J)
squalane (UNII: GW89575KF9)
caffeine (UNII: 3G6A5W338E)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
urea (UNII: 8W8T17847W)
medium-chain triglycerides (UNII: C9H2L21V7U)
hexylene glycol (UNII: KEH0A3F75J)
hyaluronate sodium (UNII: YSE9PPT4TH)
pantethine (UNII: 7K81IL792L)
sodium hydroxide (UNII: 55X04QC32I)
trehalose (UNII: B8WCK70T7I)
gamma oryzanol (UNII: SST9XCL51M)
tromethamine (UNII: 023C2WHX2V)
glycerin (UNII: PDC6A3C0OX)
docosanol (UNII: 9G1OE216XY)
caprylyl glycol (UNII: 00YIU5438U)
edetate disodium (UNII: 7FLD91C86K)
linalool, (+/-)- (UNII: D81QY6I88E)
citral (UNII: T7EU0O9VPP)
sorbic acid (UNII: X045WJ989B)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
chlorphenesin (UNII: I670DAL4SZ)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
bismuth oxychloride (UNII: 4ZR792I587)
ferric ammonium ferrocyanide (UNII: 9R0NVI936I)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-001-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2011

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL(59427-001) , REPACK(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59427-001) , RELABEL(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-001)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(59427-001)