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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ORIGINS
A PERFECT WORLD™ AGE DEFENSE TINTED MOISTURIZER SPF 15

Drug Facts

Active ingredientsPurpose
octinoxate 7.50%Sunscreen
octisalate 5.00%Sunscreen
avobenzone 2.00%Sunscreen

Uses

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:

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

©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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
ORIGINS   A PERFECT WORLD AGE DEFENSE TINTED MOISTURIZER SPF 15
octinoxate, octisalate, and avobenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate7.5 mL  in 100 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate5 mL  in 100 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59427-001-011 in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/2011
Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
Establishment
NameAddressID/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL(59427-001) , REPACK(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59427-001) , RELABEL(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE(59427-001) , RELABEL(59427-001) , REPACK(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59427-001)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(59427-001)

Revised: 2/2012
Document Id: 13d96107-e053-472d-aeaf-98cd1e2773ef
Set id: 9f78ab71-980b-48cf-b9d1-92175f888b73
Version: 1
Effective Time: 20120213
 
ORIGINS NATURAL RESOURCES INC.