PLANTSCRIPTION ANTI-AGING BROAD SPECTRUM SPF 25- avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream

PLANTSCRIPTION ANTI-AGING BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

PLANTSCRIPTION ANTI-AGING BROAD SPECTRUM SPF 25 by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
avobenzone 2.00%	Sunscreen
homosalate 5.00%	Sunscreen
octinoxate 7.50%	Sunscreen
octisalate 5.00%	Sunscreen
oxybenzone 3.00%	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 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 dimethicone butyloctyl salicylate butylene glycol glycerin steareth-2 pentylene glycol caprylic/capric/myristic/stearic triglyceride steareth-21 polysilicone-11 anogeissus leiocarpus bark extract rosa damascena flower oil1, lavandula angustifolia (lavender) oil1, pelargonium graveolens flower oil1, ilicium verum (anise) fruit/seed 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 sigesbeckia orientalis (st. paul's wort) extract polygonum cuspidatum root extract centaurium erythraea (centaury) extract rubus idaeus (raspberry) leaf extract rosmarinus officinalis (rosemary) leaf extract glycyrrhiza glabra (licorice) leaf extract aloe barbadensis leaf extract poria cocos sclerotium extract triticum vulgare (wheat) germ extract hordeum vulgare (barley) extract\extrait d'orge trehalose tetrahexyldecyl ascorbate sodium hyaluronate caffeine salicylic acid acetyl hexapeptide-8 polyethylene cetyl ricinoleate hydrogenated lecithin caprylyl methicone cocos nucifera (coconut) oil behenyl alcohol biosaccharide gum - 1 cholesterol lecithin pvp/hexadecene copolymer linoleic acid di-c12-15 alkyl fumarate sodium pca peg-100 stearate zinc pca glyceryl steaarte squalane arginine stearyl alcohol phospholipids tocopheryl acetate carbomer sodium hydroxide tromethamine disodium edta potassium sorbate sorbic acid chlorphenesin phenoxyethanol <iln39399>

1 essential oil

Other information

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

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

ORIGINS

Plantscription™ SPF 25
Anti-aging cream

Broad Spectrum SPF 25
net wt./poids net 1.7 oz./50 ml e

INGREDIENTS AND APPEARANCE

PLANTSCRIPTION ANTI-AGING BROAD SPECTRUM SPF 25 
avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.02 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.05 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butyloctyl salicylate (UNII: 2EH13UN8D3)
butylene glycol (UNII: 3XUS85K0RA)
glycerin (UNII: PDC6A3C0OX)
steareth-2 (UNII: V56DFE46J5)
pentylene glycol (UNII: 50C1307PZG)
steareth-21 (UNII: 53J3F32P58)
anogeissus leiocarpus bark (UNII: U5TP1X38RH)
rosa x damascena flower oil (UNII: 18920M3T13)
lavender oil (UNII: ZBP1YXW0H8)
pelargonium graveolens flower oil (UNII: 3K0J1S7QGC)
star anise oil (UNII: 6RXP35EIRE)
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)
geraniol (UNII: L837108USY)
linalool, (+/-)- (UNII: D81QY6I88E)
.beta.-citronellol, (r)- (UNII: P01OUT964K)
reynoutria japonica root (UNII: 7TRV45YZF7)
centaurium erythraea (UNII: 57X4TSH58S)
rubus idaeus leaf (UNII: 8O2V33JG64)
rosemary (UNII: IJ67X351P9)
glycyrrhiza glabra leaf (UNII: GH32M797Y9)
aloe vera leaf (UNII: ZY81Z83H0X)
wheat germ (UNII: YR3G369F5A)
trehalose (UNII: B8WCK70T7I)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
hyaluronate sodium (UNII: YSE9PPT4TH)
caffeine (UNII: 3G6A5W338E)
salicylic acid (UNII: O414PZ4LPZ)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
high density polyethylene (UNII: UG00KM4WR7)
cetyl ricinoleate (UNII: 1P677500YD)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
coconut oil (UNII: Q9L0O73W7L)
docosanol (UNII: 9G1OE216XY)
biosaccharide gum-1 (UNII: BB4PU4V09H)
cholesterol (UNII: 97C5T2UQ7J)
linoleic acid (UNII: 9KJL21T0QJ)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
peg-100 stearate (UNII: YD01N1999R)
zinc pidolate (UNII: C32PQ86DH4)
glyceryl monostearate (UNII: 230OU9XXE4)
squalane (UNII: GW89575KF9)
arginine (UNII: 94ZLA3W45F)
stearyl alcohol (UNII: 2KR89I4H1Y)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
sodium hydroxide (UNII: 55X04QC32I)
tromethamine (UNII: 023C2WHX2V)
edetate disodium (UNII: 7FLD91C86K)
potassium sorbate (UNII: 1VPU26JZZ4)
sorbic acid (UNII: X045WJ989B)
chlorphenesin (UNII: I670DAL4SZ)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-006-01	1 in 1 CARTON	11/01/2012
1		50 mL in 1 JAR; 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	11/01/2012

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-006) , REPACK(59427-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-006)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-006)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59427-006) , REPACK(59427-006)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59427-006) , REPACK(59427-006)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-006)