FC5® Oil-Absorbing Day Broad Spectrum SPF 20 Sunscreen

FC5 Oil-Absorbing Day Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

FC5 Oil-Absorbing Day Broad Spectrum SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FC5 OIL-ABSORBING DAY BROAD SPECTRUM SPF 20 SUNSCREEN- avobenzone, octinoxate, octisalate, and octocrylene lotion 
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® Oil-Absorbing Day Broad Spectrum SPF 20 Sunscreen

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, corn starch modified, actinidia chinensis (kiwi) fruit extract, hedera helix (ivy) extract, malva sylvestris (mallow) flower extract, melissa officinalis extract, nasturtium officinale 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 - 50 mL Bottle Carton

ARBONNE®

+ FC5®

Oil-Absorbing
Day Lotion

Broad Spectrum
SPF 20 Sunscreen

O/C

1.7 fl. oz./50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
FC5 OIL-ABSORBING DAY BROAD SPECTRUM SPF 20 SUNSCREEN 
avobenzone, octinoxate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42508-231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE18 mg  in 1 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 100 (UNII: RO266O364U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
KIWI FRUIT (UNII: 71ES77LGJC)  
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)  
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
1NDC: 42508-231-061 in 1 CARTON06/01/201212/18/2019
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/201212/18/2019
Labeler - Arbonne International, LLC (021541164)

Revised: 12/2019
Document Id: ede5377d-ee13-47d7-bb27-32c4d11d9b2e
Set id: 8bb201f1-37b2-4e6b-a540-075161a93100
Version: 3
Effective Time: 20191223
 
Arbonne International, LLC