Protective Foundation Sunscreen SPF 15

Manufacturer
Sunrider Manufacturing L.P.
Effective date
2013-02-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:34:36

Label at a glance#

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

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

USES: HELPS PREVENT SUNBURNS.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

OCTINOXATE 6%
AVOBENZONE 2%

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: WATER (DEIONIZED), GLYCERETH-26, CAPRYLIC/CAPRIC/STEARIC TRIGLLYCERIDE, ISOPROPYL PALMITATE, KAOLIN, PROPYLENE GLYCOL, POLYSORBATE 20, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, PRUNUS AMYGDALUS DULCIS (SWEEK ALMOND)OIL, SIMMONDSIA CHINENSIS (JOJOBA) OIL, AHNFELTIA CONCINNA EXTRACT, SODIUM HYALURONATE, TOCOPHEROL, SORBITAN STEARATE, SORBITAN PALMITATE, CETYL ALCOHOL, BIS-DIGLYCERYL POLYACYLADIPATE-2, PHENOXYETHANOL, TRIETHANOLAMINE, MAGNESIUM ALUMINUM SILICATE, LECITHIN, OLETH-20, SQUALENE (VEG ORIGIN), CORN STARCH MODIFIED, CELLULOSE GUM, CITRIC ACID, TRISODIUM EDTA, BUTYLENE, BUTYLPARABEN, MAY CONTAIN:TITANIUM DIOXIDE, IRON OXIDE.

WARNINGS SECTION

WARNINGS: FOR EXTERNAL USE ONLY, IF SWALLOWED SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY, IF CONTACT WITH EYES OCCURS, RINSE THOROUGHLY WITH WATER, DISCONTINUE USE AND CONSULT A DOCTOR IF PERSISTENT SIGNS OF IRRITATION OR RASH APPEAR.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton
image of carton label
image of carton label
pump
image of pump label
image of pump label




FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62191-007-022019-11-27C16284748780-19855d018-e078-cd31-e053-dbdaa90ab51aProtective Foundation Sunscreen SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62191-007-02Protective Foundation Sunscreen SPF 1530 g in 1 TUBEEMULSION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62191-007PROTECTIVE FOUNDATION SUNSCREEN SPF 15 (SUNSCREEN, AVOBENZONE, OCTINOXATE) EMULSION [SUNRIDER MANUFACTURING L.P.]2Legacy NDC, 1 package rows20130216_172ce1b6-4f93-4f2e-95f7-7315a5f2b6fd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
1-BUTENEINACTIVE INGREDIENTLY001N554L2
AHNFELTIOPSIS CONCINNAINACTIVE INGREDIENTSMF2K46G8D2
ALMOND OILINACTIVE INGREDIENT66YXD4DKO92
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV82
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3112
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB2
GLYCERETH-26INACTIVE INGREDIENTNNE56F2N142
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M2
KAOLININACTIVE INGREDIENT24H4NWX5CO2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC2
OLETH-20INACTIVE INGREDIENTYTH167I2AG2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SORBITAN MONOPALMITATEINACTIVE INGREDIENT77K6Z421KU2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X2
SQUALENEINACTIVE INGREDIENT7QWM220FJH2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
TRICAPRININACTIVE INGREDIENTO1PB8EU98M2
TRICAPRYLININACTIVE INGREDIENT6P928589882
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62191-00762191-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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 7 · 419 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / RECTAL14480 mgExact identifier — unii candidate
17 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAMUSCULAR28 mgExact identifier — unii candidate
88 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii candidate
88 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, EXTENDED RELEASE / ORAL21 mgExact identifier — unii candidate
13 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MOINTMENT / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM / BUCCAL18 mgExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCOINTMENT / VAGINAL231 mgExact identifier — unii candidate
17 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii candidate
88 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSYRUP / ORAL100 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / RESPIRATORY (INHALATION)8 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / SUBLINGUAL24 mgExact identifier — unii candidate
88 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 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
98c5593a-c1f3-44bc-af6e-0f21fbbea81d172ce1b6-4f93-4f2e-95f7-7315a5f2b6fd2013-02-13WarningsExact identifier
spl id: 98c5593a-c1f3-44bc-af6e-0f21fbbea81d
spl set id: 172ce1b6-4f93-4f2e-95f7-7315a5f2b6fd

Reported adverse events (FAERS/openFDA)#

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