FDA.reportPublic FDA data

Protective Foundation Sunscreen SPF 15

Manufacturer
Sunrider Manufacturing L.P.
Effective date
2021-12-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:45:31

Label at a glance#

ProductProtective Foundation Sunscreen SPF 15 406 Medium Beige
Active ingredientAVOBENZONE, OCTINOXATE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

USES:

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun.

DOSAGE & ADMINISTRATION SECTION

RECOMMENDATION: PLACE A SMALL AMOUNT ON A SPONGE, BLEND EVENLY OVER FACE

DIRECTIONS:

  • apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin againg. 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, expecially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

OCTINOXATE 6%
AVOBENZONE 2%

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: 

Water (Deionized)
Glycereth-26
Caprylic/Capric/Myristic/Stearic Triglyceride
Isopropyl Palmitate
Kaolin
Propylene Glycol
Polysorbate 20
Glyceryl Stearate
Stearic Acid (Veg. Origin)
Dimethicone
Prunus Amygdalus Dulcis (Sweet Almond) Oil
Simmondsia Chinensis (Jojoba) Seed Oil
Ahnfeltia Concinna Extract
Sodium Hyaluronate
Tocopherol
Sorbitan Stearate
Sorbitan Palmitate
Cetyl Alcohol
Bis-Diglyceryl Polyacyladipate-2
Phenoxyethanol
Triethanolamine
Magnesium Aluminum Silicate
Oleth-20
Squalane (Veg. Origin)
Corn Starch Modified
Cellulose Gum
Citric Acid
Trisodium EDTA
Butylene Glycol
Ethylhexylglycerin

WARNINGS SECTION

WARNINGS:

FOR EXTERNAL USE ONLY

Do not use on damaged or broken skin

When using this product keep oout of eyes. Rinse with water to remove.

Sto use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pump labelpump labelboxboxbox labelbox label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62191-406-042024-01-30C16284748780-11030e365-0fc0-111a-e063-dadaa90a10e2Protective Foundation Sunscreen SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62191-406-04Protective Foundation Sunscreen SPF 15406 Medium Beige1 in 1 PACKAGEEMULSION16
62191-406-04Protective Foundation Sunscreen SPF 15406 Medium Beige30 g in 1 TUBEEMULSION306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62191-406PROTECTIVE FOUNDATION SUNSCREEN SPF 15 406 MEDIUM BEIGE (SUNSCREEN, AVOBENZONE, OCTINOXATE) EMULSION [SUNRIDER MANUFACTURING L.P.]6Legacy NDC, 2 package rows20211209_b064623a-e879-4189-ad34-0f7ba9346c23.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62191-40662191-406-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
water059QF0KO0RIACT
ALMOND OIL66YXD4DKO9IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE TRISODIUM420IP921MBIACT
GLYCERETH-26NNE56F2N14IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
KAOLIN24H4NWX5COIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
OLETH-20YTH167I2AGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN MONOPALMITATE77K6Z421KUIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SQUALENE7QWM220FJHIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
TRICAPRINO1PB8EU98MIACT
TRICAPRYLIN6P92858988IACT
TROLAMINE9O3K93S3TKIACT
AHNFELTIOPSIS CONCINNASMF2K46G8DIACT
CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDEZF29F7IK5IIACT
JOJOBA OIL724GKU717MIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIEDQG4MW19XYXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TITANIUM DIOXIDE15FIX9V2JPCNTM
BROWN IRON OXIDE1N032N7MFOCNTM

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
e685fcaa-2686-45fa-945e-362d625044bbb064623a-e879-4189-ad34-0f7ba9346c232021-12-08WarningsExact identifier
spl id: e685fcaa-2686-45fa-945e-362d625044bb
spl set id: b064623a-e879-4189-ad34-0f7ba9346c23

Reported adverse events (FAERS/openFDA)#

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