SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20- octinoxate, octisalate, and oxybenzone cream

SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20 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
octinoxate 7.50%	Sunscreen
octisalate 4.00%	Sunscreen
oxybenzone 3.50%	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 trioctyldodecyl citrate silica phenyl trimethicone butylene glycol glyceryl stearate behenyl alcohol dimethicone octyldodecyl stearoyl stearate peg-40 stearate polyglyceryl-10 pentastearate pentylene glycol citrus aurantium bergamia (bergamot) fruit oil1, citrus limon (lemon) peel oil1, citrus aurantium dulcis (orange) peel oil1, cinnamomum camphora (camphor) bark oil1, mentha viridis (spearmint) leaf oil1, magnolia acuminata flower extract, iris pallida root extract, rosa damascena extract, citral, linalool, limonene algae extract camellia sinensis (white tea) leaf extract camellia sinensis (green tea) leaf extract sapindus mukurossi fruit extract glycyrrhiza glabra (licorice) root extract laminaria saccharina extract thermus thermophillus ferment triticum vulgare (wheat) germ extract hordeum vulgare (barley) extract\extrait d'orge castanea sativa (chestnut) seed extract salicylic acid cholesterol sucrose caffeine arginine macadamia ternifolia seed oil hydrogenated polyisobutene hydrogenated lecithin tocopheryl acetate ethylhexylglycerin glycerin caesalpinia spinosa gum isopropyl myristate lecithin polyquaternium-51 sodium stearoyl lactylate ammonium acryloyldimethyltaurate/vp copolymer squalane sodium pca urea glycyrrhetinic acid polymethyl methacrylate sodium hyaluronate galactoarabinan sodium dehydroacetate citric acid phospholipids trehalose xanthan gum ascorbyl tocopheryl maleate disodium edta bht phenoxyethanol [+/- titanium dioxide (ci 77891) iron oxides (ci 77491, ci 77492, ci 77499) mica] <iln40554>

1 essential oil

Other information

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

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton

ORIGINS

Smarty Plants™
CC

SPF 20
Skin complexion
corrector

Broad Spectrum SPF 20
1.4 fl. oz./oz. liq./40 ml e

INGREDIENTS AND APPEARANCE

SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20 
octinoxate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.079875 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0426 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03621 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
trioctyldodecyl citrate (UNII: 35X8CT063R)
silicon dioxide (UNII: ETJ7Z6XBU4)
phenyl trimethicone (UNII: DR0K5NOJ4R)
butylene glycol (UNII: 3XUS85K0RA)
glyceryl monostearate (UNII: 230OU9XXE4)
docosanol (UNII: 9G1OE216XY)
dimethicone (UNII: 92RU3N3Y1O)
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)
peg-40 stearate (UNII: ECU18C66Q7)
pentylene glycol (UNII: 50C1307PZG)
bergamot oil (UNII: 39W1PKE3JI)
lemon oil (UNII: I9GRO824LL)
orange oil (UNII: AKN3KSD11B)
camphor oil (UNII: 75IZZ8Y727)
spearmint oil (UNII: C3M81465G5)
magnolia acuminata flower (UNII: 8LCB7ZW9UL)
iris pallida root (UNII: LVV57EM5OG)
citral (UNII: T7EU0O9VPP)
linalool, (+/-)- (UNII: D81QY6I88E)
green tea leaf (UNII: W2ZU1RY8B0)
sapindus mukorossi fruit (UNII: 66H9NW427Y)
glycyrrhiza glabra (UNII: 2788Z9758H)
saccharina latissima (UNII: 68CMP2MB55)
thermus thermophilus lysate (UNII: 775R692494)
wheat germ (UNII: YR3G369F5A)
spanish chestnut (UNII: 2MT5XMR2YW)
salicylic acid (UNII: O414PZ4LPZ)
cholesterol (UNII: 97C5T2UQ7J)
sucrose (UNII: C151H8M554)
caffeine (UNII: 3G6A5W338E)
arginine (UNII: 94ZLA3W45F)
macadamia oil (UNII: 515610SU8C)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
ethylhexylglycerin (UNII: 147D247K3P)
glycerin (UNII: PDC6A3C0OX)
caesalpinia spinosa resin (UNII: WL3883U2PO)
isopropyl myristate (UNII: 0RE8K4LNJS)
sodium stearoyl lactylate (UNII: IN99IT31LN)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
squalane (UNII: GW89575KF9)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
urea (UNII: 8W8T17847W)
enoxolone (UNII: P540XA09DR)
hyaluronate sodium (UNII: YSE9PPT4TH)
galactoarabinan (UNII: SL4SX1O487)
sodium dehydroacetate (UNII: 8W46YN971G)
citric acid monohydrate (UNII: 2968PHW8QP)
trehalose (UNII: B8WCK70T7I)
xanthan gum (UNII: TTV12P4NEE)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
edetate disodium (UNII: 7FLD91C86K)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-111-01	1 in 1 CARTON	06/01/2013
1		40 mL in 1 TUBE; 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	06/01/2013

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-111) , REPACK(59427-111)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-111)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-111)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-111)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-111)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59427-111) , REPACK(59427-111)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59427-111) , REPACK(59427-111)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-111)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-111)