SYS- octinoxate, titanium dioxide lotion 
AdvoCare International L.P.

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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SYS

Drug Facts

Active Ingredients

Octinoxate 7.5%

Titanium Dioxide 6.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. If contact occures 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

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 of 15 or higher and other sun protection measures including:

Inactive ingredients

water, cyclopentasiloxane, glycerin, cetyl ethylhexanoate, tribehenin PEG-20 esters, caprylyl methicone, dimethicone, stearic acid, polyglyceryl-3 polydimethylsiloxyethyl dimethicone, polysorbate 80, aluminum hydroxide, squalane, isohexadecane, sodium acrylate/sodium acryloyldimehtyl taurate/acrylamide copolymer, hydroxyacetophenone, dimethicone/PEG-10/15 corosspolymer, cetyl alcohol, nylon-12, linoleic acid, palmitoyl tripeptide-5, 1,2-hexanediol, caprylyl glycol, dextrin, hydrolyzed hibiscus esculentus extract, sodium hyaluronate, xanthan gum, tocopherol, disodium EDTA, sodium hydroxide, vitis vinifera (grape) seed extract, glycine soja (Soybean) oil, fragrance, algae extract, glycine soja (soybean) seed extract, ergocalciferol, linolenic acid, camellia sinensis leaf extract, aloe barbadensis leaf extract, potassium sorbate, sodium benzoate, ascorbic acid

Other Information

Questions or comments?

Call 800-542-4800

Made in USA. Manufactured for and distributed by AdvoCare International L.P. Plano, TX 75074 www.advocare.com

Principal Display

SYS

supplement your skin

day

moisturizer

with sunscreen

broad specturm SPF 20

with vitamins C, D, E and F

and hibiscus and grape seed extracts

carton image

SYS 
octinoxate, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68990-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SQUALANE (UNII: GW89575KF9)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)  
NYLON-12 (UNII: 446U8J075B)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
SOYBEAN OIL (UNII: 241ATL177A)  
SOYBEAN (UNII: L7HT8F1ZOD)  
ERGOCALCIFEROL (UNII: VS041H42XC)  
LINOLENIC ACID (UNII: 0RBV727H71)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68990-001-0150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2014
Labeler - AdvoCare International L.P. (799232707)

Revised: 6/2014
Document Id: af1ae44b-daee-435f-92f3-fc332e54f383
Set id: dfc6b304-6786-436d-8760-a8222cd807cd
Version: 1
Effective Time: 20140618
 
AdvoCare International L.P.