PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION- octinoxate and titanium dioxide liquid

PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION by

Drug Labeling and Warnings

PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder 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, Pennsylvania Logistics Center. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
octinoxate 3.00%	Sunscreen
titanium dioxide 1.40%	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 cyclopentasiloxane phenyl trimethicone peg-10 dimethicone butylene glycol dimethicone isocetyl alcohol caprylic/capric triglyceride isododecane wheat germ glycerides magnesium sulfate tribehenin anogeissus leiocarpus bark extract rosa damascena flower oil1, lavandula angustifolia (lavender) oil1, pelargonium graveolens flower oil1, illicium verum (anise) oil1, citrus aurantium bergamia (bergamot) fruit oil1, carthamus tinctorius (safflower) seed oil1, myristica fragrans (nutmeg) kernel oil1, citrus aurantium dulcis (orange) oil1, citrus nobilis (mandarin orange) peel oil1, citrus medica limonum (lemon) peel oil1, litsea cubeba fruit oil1, hibiscus abelmoschus extract, geraniol, linalool, citronellol, limonene mimosa tenuiflora bark extract salvia sclarea (clary) extract scutellaria baicalensis root extract sigesbeckia orientalis (st. paul's wort) extract foeniculum vulgare (fennel) seed extract disteardimonium hectorite hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract castanea sativa (chestnut) seed extract centaurium erythraea (centaury) extract anthemis nobilis (chamomile) flower extract simmondsia chinensis (jojoba) seed oil peg/ppg-18/18 dimethicone glycerin squalane polysilicone-11 ethylhexyl palmitate cholesterol linoleic acid ethylhexylglycerin methicone polymethylsilsesquiane palmitoyl oligopeptide caffeine tocopheryl acetate sodium hyaluronate sorbitan sesquioleate sorbitan stearate aminopropyl ascorbyl phosphate trehalose triethyl citrate hydrogenated lecithin propylene carbonate sorbitan isostearate laureth-7 maltodextrin ascorbyl palmitate xanthan gum alumina chloroxylenol phenoxyethanol [+/- titanium dioxide (ci 77891) iron oxides (ci 77491, ci 77492, ci 77499)] <iln38729>

1 essential oil

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 - 30 ml Bottle Carton

ORIGINS

Plantscription™
SPF 15

Anti-aging foundation

Broad Spectrum SPF 15
1 fl. oz./oz. liq./30 ml e

INGREDIENTS AND APPEARANCE

PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
butylene glycol (UNII: 3XUS85K0RA)
dimethicone (UNII: 92RU3N3Y1O)
isocetyl alcohol (UNII: 1800H64066)
medium-chain triglycerides (UNII: C9H2L21V7U)
isododecane (UNII: A8289P68Y2)
wheat germ oil (UNII: 14C97E680P)
magnesium sulfate (UNII: DE08037SAB)
tribehenin (UNII: 8OC9U7TQZ0)
anogeissus leiocarpus bark (UNII: U5TP1X38RH)
rosa damascena flower oil (UNII: 18920M3T13)
lavender oil (UNII: ZBP1YXW0H8)
pelargonium graveolens flower oil (UNII: 3K0J1S7QGC)
bergamot oil (UNII: 39W1PKE3JI)
safflower oil (UNII: 65UEH262IS)
nutmeg oil (UNII: Z1CLM48948)
orange oil (UNII: AKN3KSD11B)
mandarin oil (UNII: NJO720F72R)
lemon oil (UNII: I9GRO824LL)
litsea oil (UNII: 2XIW34BN6O)
abelmoschus moschatus seed (UNII: UN2QZ55I88)
geraniol (UNII: L837108USY)
linalool, (+/-)- (UNII: D81QY6I88E)
.beta.-citronellol, (r)- (UNII: P01OUT964K)
mimosa tenuiflora bark (UNII: 515MQE449I)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
fennel seed (UNII: G3QC02NIE6)
wheat germ (UNII: YR3G369F5A)
spanish chestnut (UNII: 2MT5XMR2YW)
centaurium erythraea (UNII: 57X4TSH58S)
chamaemelum nobile flower (UNII: O2T154T6OG)
jojoba oil (UNII: 724GKU717M)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
glycerin (UNII: PDC6A3C0OX)
squalane (UNII: GW89575KF9)
ethylhexyl palmitate (UNII: 2865993309)
cholesterol (UNII: 97C5T2UQ7J)
linoleic acid (UNII: 9KJL21T0QJ)
ethylhexylglycerin (UNII: 147D247K3P)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
caffeine (UNII: 3G6A5W338E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
hyaluronate sodium (UNII: YSE9PPT4TH)
sorbitan sesquioleate (UNII: 0W8RRI5W5A)
sorbitan monostearate (UNII: NVZ4I0H58X)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
trehalose (UNII: B8WCK70T7I)
triethyl citrate (UNII: 8Z96QXD6UM)
propylene carbonate (UNII: 8D08K3S51E)
sorbitan isostearate (UNII: 01S2G2C1E4)
laureth-7 (UNII: Z95S6G8201)
maltodextrin (UNII: 7CVR7L4A2D)
ascorbyl palmitate (UNII: QN83US2B0N)
xanthan gum (UNII: TTV12P4NEE)
aluminum oxide (UNII: LMI26O6933)
chloroxylenol (UNII: 0F32U78V2Q)
phenoxyethanol (UNII: HIE492ZZ3T)
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: 59427-004-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2012

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(59427-004) , REPACK(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59427-004) , RELABEL(59427-004) , REPACK(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59427-004) , RELABEL(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(59427-004) , RELABEL(59427-004) , REPACK(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(59427-004) , RELABEL(59427-004) , REPACK(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(59427-004) , RELABEL(59427-004) , REPACK(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(59427-004)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(59427-004) , RELABEL(59427-004)