FC5® Complexion Revitalizing Set

FC5 Complexion Revitalizing Set by

Drug Labeling and Warnings

FC5 Complexion Revitalizing Set by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FC5 COMPLEXION REVITALIZING SET- avobenzone, octinoxate, octisalate, and octrocrylene 
Arbonne International, LLC

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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FC5® Complexion Revitalizing Set

Drug Facts

Active ingredients

Avobenzone 2.0%
Octinoxate 7.5%
Octisalate 5.0%
Octocrylene 1.8%

Purpose

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 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 10 a.m.–2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: ask a doctor

Other information

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

Inactive ingredients

water, C12-15 alkyl benzoate, glycerin, glyceryl stearate, PEG-100 stearate, dimethicone, cetearyl alcohol, actinidia chinensis (kiwi) fruit extract, betula alba leaf extract, cucumis sativus (cucumber) fruit extract, melissa officinalis extract, nasturtium officinale extract, trifolium pratense (clover) flower extract, vitis vinifera (grape) seed extract, punica granatum extract, retinyl palmitate, tocopherol, magnesium ascorbyl phosphate, ceteareth-20, carbomer, polyisobutene, polysorbate 20, polyacrylate-13, aminomethyl propanol, butylene glycol, ethylhexylglycerin, disodium EDTA, allyl caproate, hexyl acetate, citrus aurantium bergamia (bergamot) fruit oil, citrus nobilis (mandarin orange) peel oil, ethyl acetate, santalum album (sandalwood) oil, geranyl acetate, citrus aurantifolia (lime) oil, citrus aurantium dulcis (orange) oil, citrus aurantium dulcis (orange) fruit extract, citrus grandis (grapefruit) peel oil, 3-hexenol, citrus limon (lemon) peel oil, cymbopogon schoenanthus oil, phenoxyethanol, potassium sorbate.

Questions or comments?

1.800.272.6663

Monday–Friday 6 a.m.–6 p.m. Pacific time

Distributed by

Arbonne International, LLC
9400 Jeronimo Road
Irvine, CA 92618 U.S.A.

PRINCIPAL DISPLAY PANEL - Kit Carton

ARBONNE®

+ FC5®

Complexion Revitalizing Set

Nurturing Day Lotion
Broad Spectrum SPF 20 Sunscreen
1.7 fl. oz./50 mL

Hydrating Cleanser + Freshener
4 fl. oz./118 mL

Moisturizing Night Crème
1.7 fl. oz./50 mL

Principal Display Panel - Kit Carton
FC5 COMPLEXION REVITALIZING SET 
avobenzone, octinoxate, octisalate, and octrocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42508-979
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42508-979-001 in 1 CARTON04/01/201312/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 50 mL
Part 21 TUBE 118 mL
Part 31 TUBE 50 mL
Part 1 of 3
FC5 NURTURING DAY 
avobenzone, octinoxate, octisalate, and octocrylene lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.8 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
KIWI FRUIT (UNII: 71ES77LGJC)  
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
CUCUMBER (UNII: YY7C30VXJT)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ALLYL HEXANOATE (UNII: 3VH84A363D)  
HEXYL ACETATE (UNII: 7U7KU3MWT0)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
MANDARIN OIL (UNII: NJO720F72R)  
ETHYL ACETATE (UNII: 76845O8NMZ)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
GERANYL ACETATE (UNII: 3W81YG7P9R)  
LIME OIL (UNII: UZH29XGA8G)  
ORANGE OIL (UNII: AKN3KSD11B)  
ORANGE (UNII: 5EVU04N5QU)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)  
LEMON OIL (UNII: I9GRO824LL)  
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
150 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 FINALpart35204/01/201312/18/2019
Part 2 of 3
FC5 HYDRATING CLEANSER PLUS FRESHENER 
cleansing (cold creams, cleansing lotions, liquids, and pads) emulsion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRALOYSIA CITRODORA FLOWERING TOP (UNII: YI915CG0D0)  
INGRPELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRPROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRCETEARYL WHEAT STRAW GLYCOSIDES (UNII: B44PS4T8IN)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRALPINE STRAWBERRY (UNII: CG6IX3GCMU)  
INGRBETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
INGRPUMMELO (UNII: ET1TN5W71X)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRGERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
INGRHYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
INGRNASTURTIUM OFFICINALE (UNII: YH89GMV676)  
INGRCLARY SAGE (UNII: U3HSK5JC0Q)  
INGRTRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
INGRYUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGRGLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRMAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRTROMETHAMINE (UNII: 023C2WHX2V)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRGLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
INGRALLYL HEXANOATE (UNII: 3VH84A363D)  
INGRHEXYL ACETATE (UNII: 7U7KU3MWT0)  
INGRBERGAMOT OIL (UNII: 39W1PKE3JI)  
INGRMANDARIN OIL (UNII: NJO720F72R)  
INGRETHYL ACETATE (UNII: 76845O8NMZ)  
INGRSANDALWOOD OIL (UNII: X7X01WMQ5F)  
INGRGERANYL ACETATE (UNII: 3W81YG7P9R)  
INGRLIME OIL (UNII: UZH29XGA8G)  
INGRORANGE OIL (UNII: AKN3KSD11B)  
INGRORANGE (UNII: 5EVU04N5QU)  
INGRCITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
INGR3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)  
INGRLEMON OIL (UNII: I9GRO824LL)  
INGRCYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC04/01/201312/18/2019
Part 3 of 3
FC5 MOISTURIZING NIGHT 
moisturizing cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRALOYSIA CITRODORA FLOWERING TOP (UNII: YI915CG0D0)  
INGRPELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
INGRISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRSORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRMANGO (UNII: I629I3NR86)  
INGRFAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
INGRBETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
INGRORANGE PEEL (UNII: TI9T76XD44)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRHYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
INGRNASTURTIUM OFFICINALE (UNII: YH89GMV676)  
INGROLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
INGRTRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
INGRMILK THISTLE (UNII: U946SH95EE)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRMAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRMYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
INGRMYRISTYL LAURATE (UNII: 58U0NZN2BT)  
INGRCARNOSINE (UNII: 8HO6PVN24W)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGRTROMETHAMINE (UNII: 023C2WHX2V)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
INGRCITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
INGRGALBANUM OIL (UNII: 211UF7M8N1)  
INGRSANDALWOOD OIL (UNII: X7X01WMQ5F)  
INGRHEXYL ACETATE (UNII: 7U7KU3MWT0)  
INGRMANDARIN OIL (UNII: NJO720F72R)  
INGRBERGAMOT OIL (UNII: 39W1PKE3JI)  
INGRETHYL ACETATE (UNII: 76845O8NMZ)  
INGRLIME OIL (UNII: UZH29XGA8G)  
INGRCYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
INGR3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)  
INGRGINGER OIL (UNII: SAS9Z1SVUK)  
INGRLEMON OIL (UNII: I9GRO824LL)  
INGRGERANYL ACETATE (UNII: 3W81YG7P9R)  
INGRALLYL HEXANOATE (UNII: 3VH84A363D)  
INGRORANGE OIL (UNII: AKN3KSD11B)  
INGRORANGE (UNII: 5EVU04N5QU)  
INGRCANANGA OIL (UNII: 8YOY78GNNX)  
INGR.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRLINALYL ACETATE (UNII: 5K47SSQ51G)  
INGR.BETA.-IONONE (UNII: A7NRR1HLH6)  
INGRGERANIOL (UNII: L837108USY)  
INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
INGR.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
INGRBENZYL ACETATE (UNII: 0ECG3V79ZJ)  
INGR3-HEXENYL ACETATE, (3Z)- (UNII: 6INA6GC5I6)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRCITRAL (UNII: T7EU0O9VPP)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC04/01/201312/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/201312/18/2019
Labeler - Arbonne International, LLC (021541164)

Revised: 12/2019
 
Arbonne International, LLC