FDA.reportPublic FDA data

SYS

Manufacturer
AdvoCare International L.P.
Effective date
2014-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:40

Label at a glance#

ProductSYS
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure13 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating Immediately after towel drying At least every 2 hours 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 of 15 or higher and other sun protection measure...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Titanium Dioxide 6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. If contact occures rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • 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 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-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 800-542-4800

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

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 imagecarton image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
a1367f07-14a3-4895-a6e7-61ee9285308bProduct name120190415
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68990-001-012019-11-27C16284748780-19855e2a2-405f-60a7-e053-dbdaa90a05bdSYS Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68990-001-01SYS50 mL in 1 BOTTLELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68990-001SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.]1Legacy NDC, 1 package rows20140702_dfc6b304-6786-436d-8760-a8222cd807cd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G1
4-HYDROXY ACETOPHENONEINACTIVE INGREDIENTG1L3HT4CMH1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CETYL ETHYLHEXANOATEINACTIVE INGREDIENT134647WMX41
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ERGOCALCIFEROLINACTIVE INGREDIENTVS041H42XC1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
ICODEXTRININACTIVE INGREDIENT2NX48Z0A9G1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJ1
LINOLENIC ACIDINACTIVE INGREDIENT0RBV727H711
NYLON-12INACTIVE INGREDIENT446U8J075B1
PALMITOYL TRIPEPTIDE-5INACTIVE INGREDIENT2A3916MQHO1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZX1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SOYBEANINACTIVE INGREDIENTL7HT8F1ZOD1
SOYBEAN OILINACTIVE INGREDIENT241ATL177A1
SQUALANEINACTIVE INGREDIENTGW89575KF91
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
TRIBEHENIN PEG-20 ESTERSINACTIVE INGREDIENT84K9EH29Y91
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68990-00168990-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
TRIBEHENIN PEG-20 ESTERS84K9EH29Y9IACT
DIMETHICONE92RU3N3Y1OIACT
STEARIC ACID4ELV7Z65APIACT
POLYSORBATE 806OZP39ZG8HIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SQUALANEGW89575KF9IACT
ISOHEXADECANE918X1OUF1EIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
4-HYDROXY ACETOPHENONEG1L3HT4CMHIACT
NYLON-12446U8J075BIACT
LINOLEIC ACID9KJL21T0QJIACT
PALMITOYL TRIPEPTIDE-52A3916MQHOIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL ALCOHOL936JST6JCNIACT
ICODEXTRIN2NX48Z0A9GIACT
HYALURONATE SODIUMYSE9PPT4THIACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
SOYBEAN OIL241ATL177AIACT
SOYBEANL7HT8F1ZODIACT
ERGOCALCIFEROLVS041H42XCIACT
LINOLENIC ACID0RBV727H71IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOE VERA LEAFZY81Z83H0XIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
ASCORBIC ACIDPQ6CK8PD0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 596 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISHAMPOO / TOPICAL3 mgExact identifier — unii candidate
174 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM, AUGMENTED / TOPICAL6 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET / ORAL80 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBCUTANEOUS1 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGEL / TOPICAL12 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / RESPIRATORY (INHALATION)8 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INFILTRATION0.2 %w/vExact identifier — unii candidate
25 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5.4 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.11 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
af1ae44b-daee-435f-92f3-fc332e54f383dfc6b304-6786-436d-8760-a8222cd807cd2014-06-18WarningsExact identifier
spl id: af1ae44b-daee-435f-92f3-fc332e54f383
spl set id: dfc6b304-6786-436d-8760-a8222cd807cd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.