OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 3.3%
Active Ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 3.3%
Inactive ingredients:
WATER, ISOAMYL p-METHOXYCINNAMATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, POLYSORBATE 80, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, RIMETHOXYCAPRYLYLSILANE, SORBITAN LAURATE, ALUMINUM HYDROXIDE, STEARIC ACID, POTASSIUM CETYL PHOSPHATE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, DIMETHICONE, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CENTELLA ASIATICA EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CARBOMER, BHT, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, TRIETHANOLAMINE, DISODIUM EDTA, RICE FERMENT FILTRATE (SAKE), PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE
Purpose: Protects skin from UV rays.
Warnings:
For external use only. Avoid contact with eyes.
Discontinue use if signs of irritation appear.
Keep out of reach of children:
Keep out of reach of children.
Indication and usage:
Use at the end of your daily skincare regimen. Apply liberally onto face and body before sun exposure avoiding the eye area.
Dosage and administration:
For best results, apply at least 15 to 20 minutes before sun exposure.
Reapply frequently while out in the sun.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76214-012-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fb0b-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76214-012-01 | PEACH SAKE SUNSPF32 PA Plus Plus | 75 mL in 1 BOTTLE | LOTION | 75 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| TITANIUM | ACTIVE MOIETY | D1JT611TNE | 2 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 2 | |
| APPLE | INACTIVE INGREDIENT | B423VGH5S9 | 2 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 2 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 2 | |
| CENTELLA ASIATICA | INACTIVE INGREDIENT | 7M867G6T1U | 2 | |
| CHAMOMILE | INACTIVE INGREDIENT | FGL3685T2X | 2 | |
| DIETHYLHEXYL CARBONATE | INACTIVE INGREDIENT | YCD50O0Z6L | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| GLYCYRRHIZA GLABRA | INACTIVE INGREDIENT | 2788Z9758H | 2 | |
| ISOHEXADECANE | INACTIVE INGREDIENT | 918X1OUF1E | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| PEACH | INACTIVE INGREDIENT | 3OKE88I3QG | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 2 | |
| POTASSIUM CETYL PHOSPHATE | INACTIVE INGREDIENT | 03KCY6P7UT | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SORBITAN MONOLAURATE | INACTIVE INGREDIENT | 6W9PS8B71J | 2 | |
| SOYBEAN | INACTIVE INGREDIENT | L7HT8F1ZOD | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TRIMETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | FZ07E4LW2M | 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 |
|---|---|
| 76214-012 | 76214-012-01 |
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 |
|---|---|---|---|---|---|---|
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SOFT TISSUE | 4 mg | ||
| ALUMINUM HYDROXIDE | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | CREAM / TOPICAL | 5 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 53 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, EXTENDED RELEASE / ORAL | 10 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / ORAL | 907 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAVENOUS | 0.5 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / TOPICAL | 20 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| SORBITAN MONOLAURATE | SORBITAN MONOLAURATE | 6W9PS8B71J | SPRAY, METERED / NASAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / RECTAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION, CONCENTRATE / ORAL | 0.1 mg/1ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GRANULE, FOR SUSPENSION / ORAL | 240 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAVITREAL | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| ALUMINUM HYDROXIDE | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | OINTMENT / TOPICAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / AURICULAR (OTIC) | 0.02 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / OPHTHALMIC | 0.05 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GUM, CHEWING / BUCCAL | 5 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRASYNOVIAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 34 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v |
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 |
|---|---|---|---|---|---|---|
| 6209c189-d628-4727-8aac-a565a7424afb | 6d5b07ab-c0a2-4494-8b07-a73573ef71c4 | 2011-09-07 | Warnings | 6209c189-d628-4727-8aac-a565a7424afb 6d5b07ab-c0a2-4494-8b07-a73573ef71c4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.