PLANTSCRIPTION ANTI AGING OIL FREE BROAD SPECTRUM SPF 25- avobenzone, octisalate, and octocrylene cream

PLANTSCRIPTION ANTI AGING OIL FREE BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

PLANTSCRIPTION ANTI AGING OIL FREE BROAD SPECTRUM SPF 25 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 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
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\aqua\eau butyloctyl salicylate ethyl macadamiate butylene glycol methyl trimethicone jojoba esters lauryl peg-9 polydimethylsiloxyethyl dimethicone glycerin peg-100 stearate glyceryl stearate anogeissus leiocarpus bark extract rosa damascena flower oil1, lavandula angustifolia (lavender) oil1, pelargonium graveolens flower oil1, illicium 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 poria cocos sclerotium extract triticum vulgare (wheat) germ extract hordeum vulgare (barley) extract\extrait d'orge tetrahexyldecyl ascorbate sodium hyaluronate caffeine salicylic acid acetyl hexapeptide-8 silica potassium cetyl phosphate butyrospermum parkii (shea butter) mangifera indica (mango) seed butter ammonium acryloyldimethyltaurate/vp copolymer lecithin linoleic acid phospholipids cholesterol squalane arginine cetyl alcohol ethylhexylglycerin sodium pca caprylyl glycol zinc pca dehydroxanthan gum potassium hydroxide stearic acid tocopheryl acetate citric acid sodium dehydroacetate phenoxyethanol mica <iln39390>

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 oil-free cream

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

INGREDIENTS AND APPEARANCE

PLANTSCRIPTION ANTI AGING OIL FREE BROAD SPECTRUM SPF 25 
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0303 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0505 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02727 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
ethyl macadamiate (UNII: ANA2NCS6V1)
butylene glycol (UNII: 3XUS85K0RA)
methyl trimethicone (UNII: S73ZQI0GXM)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
glycerin (UNII: PDC6A3C0OX)
peg-100 stearate (UNII: YD01N1999R)
glyceryl monostearate (UNII: 230OU9XXE4)
anogeissus leiocarpus bark (UNII: U5TP1X38RH)
rosa 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)
polygonum cuspidatum root (UNII: 7TRV45YZF7)
centaurium erythraea (UNII: 57X4TSH58S)
rubus idaeus leaf (UNII: 8O2V33JG64)
rosemary (UNII: IJ67X351P9)
glycyrrhiza glabra leaf (UNII: GH32M797Y9)
wheat germ (UNII: YR3G369F5A)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
hyaluronate sodium (UNII: YSE9PPT4TH)
caffeine (UNII: 3G6A5W338E)
salicylic acid (UNII: O414PZ4LPZ)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
silicon dioxide (UNII: ETJ7Z6XBU4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
shea butter (UNII: K49155WL9Y)
mangifera indica seed butter (UNII: 4OXD9M35X2)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
linoleic acid (UNII: 9KJL21T0QJ)
cholesterol (UNII: 97C5T2UQ7J)
squalane (UNII: GW89575KF9)
arginine (UNII: 94ZLA3W45F)
cetyl alcohol (UNII: 936JST6JCN)
ethylhexylglycerin (UNII: 147D247K3P)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
caprylyl glycol (UNII: 00YIU5438U)
zinc pidolate (UNII: C32PQ86DH4)
potassium hydroxide (UNII: WZH3C48M4T)
stearic acid (UNII: 4ELV7Z65AP)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
citric acid monohydrate (UNII: 2968PHW8QP)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-007-01	1 in 1 CARTON
1		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	11/01/2012

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(59427-007) , REPACK(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59427-007) , RELABEL(59427-007) , REPACK(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59427-007) , RELABEL(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(59427-007) , RELABEL(59427-007) , REPACK(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(59427-007) , RELABEL(59427-007) , REPACK(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(59427-007) , RELABEL(59427-007) , REPACK(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(59427-007)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	RELABEL(59427-007) , REPACK(59427-007)