FDA.reportPublic FDA data

FOUNDATION MEDIUM SPECTRUM

Manufacturer
Guangzhou Bo win Trade Co., Ltd.
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:37:56

Label at a glance#

ProductFOUNDATION MEDIUM SPECTRUM
Active ingredientZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxycinnamate 7.5%
Zinc Oxide 5%
Titanium Dioxide 5%

OTC - PURPOSE SECTION

Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

lf swallowed, contact a physician orpoison control center right away.

INDICATIONS & USAGE SECTION

helps prevent sunbum

if used as directed with other sunprotection measures (see Directions)decreases the risk of skin cancer andearly skin aging caused by the sun

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product keep out ofeyes. Rinse with water to remove.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 minutesbefore sun exposure
Reapply at least every two hours
Use a water-resistant sunscreen ifswimming or sweating
Sun Protection Measures. Spendingtime in the sun increases your risk ofskin cancer and early skin aging.Todecrease this risk, regularly use asunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sunprotection measures including:- Limit time in the sun, especially from10 a.m.- 2 p.m.-Wear long-sleeved shirts, pants, hatsand sunglasses
children under 6 months of age:Ask a doctor

INACTIVE INGREDIENT SECTION

Quaternary ammonium compounds
ISOPROPYL PALMITATE
Dimethyl cyclosiloxane
SILICA
PEG-10 Dimethicone
SORBITAN SESQUIOLEATE
MAGNESIUM STEARATE
Methacrylic acid
WATER
GLYCERIN
Propylene glycol
sodium chloride
Erythritol
CI 77492
CI 77491
CI 77499
Sorbitol powder
Aloe Vera Extract
2-phenoxyethanol
Poly(vinyl alcohol)
Ethyl cellulose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84958-002-01FOUNDATION MEDIUM SPECTRUM30 g in 1 BOTTLELIQUID301
84958-002-01FOUNDATION MEDIUM SPECTRUM1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84958-002FOUNDATION MEDIUM SPECTRUM (OCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDE) LIQUID [GUANGZHOU BO WIN TRADE CO., LTD.]1Current NDC, 2 package rows20241121_273f4d65-b245-c27a-e063-6394a90ade07.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84958-00284958-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
CYCLOMETHICONENMQ347994ZIACT
PEG-10 DIMETHICONE (900 CST)53D6AAS8X8IACT
CI 77492EX438O2MRTIACT
SODIUM CHLORIDE451W47IQ8XIACT
OCTINOXATE4Y5P7MUD51ACTIB
SILICAETJ7Z6XBU4IACT
METHACRYLIC ACID1CS02G8656IACT
WATER059QF0KO0RIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CI 77499XM0M87F357IACT
CI 774911K09F3G675IACT
ERYTHRITOLRA96B954X6IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALOE VERA LEAF EXTRACTZY81Z83H0XIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
C8-10 TRIALKYLMETHYL QUATERNARY AMMONIUM CHLORIDESYNE6ALT384IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
MAGNESIUM STEARATE70097M6I30IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

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
FOUNDATION MEDIUM SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273f4d65-b245-c27a-e063-6394a90ade072024-11-19WarningsExact identifier
ndc (package): 84958-002-01
ndc (product): 84958-002
ndc11 (package): 84958000201
spl id: 273f4d65-b246-c27a-e063-6394a90ade07
spl set id: 273f4d65-b245-c27a-e063-6394a90ade07

Reported adverse events (FAERS/openFDA)#

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