OTC - PURPOSE SECTION
USES: HELPS PREVENT SUNBURNS.
USES: HELPS PREVENT SUNBURNS.
RECOMMENDATION: PLACE A SMALL AMOUNT ON A SPONGE, BLEND EVENLY OVER FACE
ACTIVE INGREDIENTS:
OCTINOXATE 6%
AVOBENZONE 2%
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: 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.
KEEP OUT OF REACH OF CHILDREN
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62191-007-02 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e078-cd31-e053-dbdaa90ab51a | Protective Foundation Sunscreen SPF 15 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62191-007-02 | Protective Foundation Sunscreen SPF 15 | 30 g in 1 TUBE | EMULSION | 30 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 2 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| 1-BUTENE | INACTIVE INGREDIENT | LY001N554L | 2 | |
| AHNFELTIOPSIS CONCINNA | INACTIVE INGREDIENT | SMF2K46G8D | 2 | |
| ALMOND OIL | INACTIVE INGREDIENT | 66YXD4DKO9 | 2 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 2 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 2 | |
| GLYCERETH-26 | INACTIVE INGREDIENT | NNE56F2N14 | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 2 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 2 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | 2 | |
| KAOLIN | INACTIVE INGREDIENT | 24H4NWX5CO | 2 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 2 | |
| OLETH-20 | INACTIVE INGREDIENT | YTH167I2AG | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SORBITAN MONOPALMITATE | INACTIVE INGREDIENT | 77K6Z421KU | 2 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 2 | |
| SQUALENE | INACTIVE INGREDIENT | 7QWM220FJH | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 2 | |
| TRICAPRIN | INACTIVE INGREDIENT | O1PB8EU98M | 2 | |
| TRICAPRYLIN | INACTIVE INGREDIENT | 6P92858988 | 2 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62191-007 | 62191-007-02 |
Every source-derived ingredient row is available through these pages.
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / RECTAL | 14480 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GRANULE, FOR SUSPENSION / ORAL | 113 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TRANSDERMAL | 14 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOAP / TOPICAL | 0.02 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| KAOLIN | KAOLIN | 24H4NWX5CO | CAPSULE, EXTENDED RELEASE / ORAL | 21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GRANULE / ORAL | NA | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | OINTMENT / TOPICAL | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / ORAL | 6 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOLUTION / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | GEL / TOPICAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | FILM / BUCCAL | 18 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY, METERED / NASAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | OINTMENT / VAGINAL | 231 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / TOPICAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INFILTRATION | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION, CONCENTRATE / INTRAVENOUS | NA | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SUSPENSION / ORAL | 560 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SYRUP / ORAL | 100 mg/1ml | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | TABLET / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / SUBLINGUAL | 24 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 98c5593a-c1f3-44bc-af6e-0f21fbbea81d | 172ce1b6-4f93-4f2e-95f7-7315a5f2b6fd | 2013-02-13 | Warnings | 98c5593a-c1f3-44bc-af6e-0f21fbbea81d 172ce1b6-4f93-4f2e-95f7-7315a5f2b6fd |
Adverse event summaries are temporarily unavailable. Other product information remains available.