PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION

Dosage form: liquid
Ingredients: OCTINOXATE 3mL in 100mL, TITANIUM DIOXIDE 1.4mL in 100mL
Labeler: ORIGINS NATURAL RESOURCES INC.
NDC Code: 59427-004

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.

PLANTSCRIPTION™ SPF 15 ANTI-AGING FOUNDATION

Drug Facts

Active ingredientsPurpose
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 oil, 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>


essential oil

Other information

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

©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

PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION 
octinoxate and titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 5 
phenyl trimethicone 
butylene glycol 
dimethicone 
isocetyl alcohol 
medium-chain triglycerides 
isododecane 
wheat germ oil 
magnesium sulfate 
tribehenin 
anogeissus leiocarpus bark 
rosa damascena flower oil 
lavender oil 
pelargonium graveolens flower oil 
bergamot oil 
safflower oil 
nutmeg oil 
orange oil 
mandarin oil 
lemon oil 
litsea oil 
abelmoschus moschatus seed 
geraniol 
linalool, (+/-)- 
.beta.-citronellol, (r)- 
mimosa tenuiflora bark 
scutellaria baicalensis root 
fennel seed 
wheat germ 
spanish chestnut 
centaurium erythraea 
chamaemelum nobile flower 
jojoba oil 
peg/ppg-18/18 dimethicone 
glycerin 
squalane 
ethylhexyl palmitate 
cholesterol 
linoleic acid 
ethylhexylglycerin 
palmitoyl oligopeptide 
caffeine 
.alpha.-tocopherol acetate 
hyaluronate sodium 
sorbitan sesquioleate 
sorbitan monostearate 
aminopropyl ascorbyl phosphate 
trehalose 
triethyl citrate 
propylene carbonate 
sorbitan isostearate 
laureth-7 
maltodextrin 
ascorbyl palmitate 
xanthan gum 
aluminum oxide 
chloroxylenol 
phenoxyethanol 
ferric oxide red 
ferric oxide yellow 
ferrosoferric oxide 
Packaging
#Item CodePackage Description
1NDC:59427-004-011 BOTTLE in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/2012
Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195RELABEL(59427-004), REPACK(59427-004)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59427-004), RELABEL(59427-004), REPACK(59427-004)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(59427-004)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59427-004), RELABEL(59427-004)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59427-004)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59427-004)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59427-004)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(59427-004)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59427-004)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(59427-004), RELABEL(59427-004), REPACK(59427-004)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(59427-004), RELABEL(59427-004), REPACK(59427-004)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(59427-004), RELABEL(59427-004), REPACK(59427-004)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59427-004)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(59427-004)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(59427-004), RELABEL(59427-004)

Revised: 06/2012
 
ORIGINS NATURAL RESOURCES INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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