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

PLANTSCRIPTION SPF 25 POWER ANTI-AGING oil FREE BROAD SPECTRUM by

Drug Labeling and Warnings

PLANTSCRIPTION SPF 25 POWER ANTI-AGING oil FREE BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients Purpose

avobenzone 3.0% Sunscreen

homosalate 5.0% Sunscreen

octisalate 4.5% Sunscreen

octocrylene 2.8% 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 nylon-12 octyldodecyl neopentanoate behenyl alcohol myristyl myristate dimethicone cetyl esters polyethylene butylene glycol ammonium acryloyldimethyltaurate/vp copolymer glycerin 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) peel oil1, citrus nobilis (mandarin orange) peel oil1, citrus limon (lemon) peel oil1, litsea cubeba fruit oil1, hibiscus abelmoschus extract, geraniol, linalool, citronellol, limonene, citral coffea arabica (coffee) seed extract sigesbeckia orientalis (st. paul's wort) extract peucedanum graveolens (dill) extract hordeum vulgare (barley) extract\extrait d'orge pisum sativum (pea) extract cholesterol micrococcus lysate bambusa vulgaris (bamboo) extract glyceryl stearate triticum vulgare (wheat) germ extract crithmum maritimum extract anogeissus leiocarpus bark extract rosmarinus officinalis (rosemary) leaf extract caffeine centaurium erythraea (centaury) extract rubus idaeus (raspberry) leaf extract cassia alata leaf extract phytosphingosine trisiloxane laminaria digitata extract acetyl hexapeptide-8 hydrolyzed algin glucosamine hcl peg-100 stearate sodium hyaluronate peg-6 di-ppg-2 myreth-10 adipate steareth-21 tocopheryl acetate caprylyl glycol ethylhexylglycerin squalane linoleic acid trehalose tetrahexyldecyl ascorbate citric acid sodium pca lecithin maltodextrin hexylene glycol sodium dehydroacetate disodium edta phenoxyethanol mica <iln42148>

1 essential oil

Active ingredients	Purpose
avobenzone 3.0%	Sunscreen
homosalate 5.0%	Sunscreen
octisalate 4.5%	Sunscreen
octocrylene 2.8%	Sunscreen

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
Power anti-aging oil-free cream

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	28 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NYLON-12 (UNII: 446U8J075B)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
DOCOSANOL (UNII: 9G1OE216XY)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ESTERS WAX (UNII: D072FFP9GU)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
GLYCERIN (UNII: PDC6A3C0OX)
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)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q)
PEA (UNII: W4X7H8GYFM)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WHEAT GERM (UNII: YR3G369F5A)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)
ROSEMARY (UNII: IJ67X351P9)
CAFFEINE (UNII: 3G6A5W338E)
CENTAURIUM ERYTHRAEA (UNII: 57X4TSH58S)
RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
TRISILOXANE (UNII: 9G1ZW13R0G)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
PEG-100 STEARATE (UNII: YD01N1999R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)
STEARETH-21 (UNII: 53J3F32P58)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SQUALANE (UNII: GW89575KF9)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
TREHALOSE (UNII: B8WCK70T7I)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 59427-012-01	1 in 1 CARTON	11/15/2017
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2017

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-012) , REPACK(59427-012)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-012)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-012)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-012)

Name	Address	ID/FEI	Business Operations
Establishment
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-012)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC INC		943871157	RELABEL(59427-012) , REPACK(59427-012)

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		949264774	RELABEL(59427-012) , REPACK(59427-012)

Name	Address	ID/FEI	Business Operations
Establishment
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-012)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-012)