SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20- octinoxate, octisalate, and oxybenzone cream 
ORIGINS NATURAL RESOURCES INC.

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.

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SMARTY PLANTS™ CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20

Drug Facts

Active ingredientsPurpose
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

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton
SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20 
octinoxate, octisalate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.079875 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0426 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.03621 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59427-111-011 in 1 CARTON06/01/2013
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/201311/12/2020
Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(59427-111) , REPACK(59427-111)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59427-111)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(59427-111)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(59427-111)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59427-111)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(59427-111) , REPACK(59427-111)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(59427-111) , REPACK(59427-111)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59427-111)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(59427-111)

Revised: 11/2020
Document Id: 2dab8941-f4fa-48b0-98bf-3c39a23ce836
Set id: a9dfa6b8-4b1a-4233-91f0-ad7423b2e04f
Version: 3
Effective Time: 20201117
 
ORIGINS NATURAL RESOURCES INC.