Indications and uses
helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
For sunscreen use: apply liberally 15 minutes before sun exposure use 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 aging. 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 su...
protect this product in this container from excessive heat and direct sun.
Drug Facts
| ACTIVE INGREDIENTS | Purpose |
|---|---|
| OCTINOXATE 1.9% | Sunscreen |
| TITANIUM DIOXIDE 1.8% | Sunscreen |
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop 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.
For sunscreen use:
TALC, POLYMETHYL METHACRYLATE, DIMETHICONE, ZINC MYRISTATE, DIISOSTEARYL MALATE, SILICA, SORBITAN SESQUIISOSTEARATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, METHICONE, TOCOPHEROL, BHT, ETHYLPARABEN, FRAGRANCE, MICA, ZINC OXIDE, IRON OXIDES, TITANIUM DIOXIDE,
Call toll free 1-800-906-7503
SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK • PARIS • MILANO
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| DIISOSTEARYL MALATE | INACTIVE INGREDIENT | QBS8A3XZGQ | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| METHICONE (20 CST) | INACTIVE INGREDIENT | 6777U11MKT | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| ZINC MYRISTATE | INACTIVE INGREDIENT | K09A9E2GGO | 1 | |
| ZINC OXIDE | INACTIVE INGREDIENT | SOI2LOH54Z | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52686-302 | 52686-302-30 |
| 52686-303 | 52686-303-30 |
| 52686-304 | 52686-304-30 |
| 52686-305 | 52686-305-30 |
| 52686-306 | 52686-306-30 |
| 52686-307 | 52686-307-30 |
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / ORAL | 14 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL, METERED / TOPICAL | 4 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | INJECTION, EMULSION / INTRAVENOUS | 0.02 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SOLUTION / RESPIRATORY (INHALATION) | 3.11 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GUM, CHEWING / BUCCAL | 5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOAP / TOPICAL | 0.02 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 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 |
|---|---|---|---|---|---|---|
| f15b9510-8869-4281-98c5-1f5281376dee | bc60460c-202e-434d-958d-98e30eb98cd1 | 2023-10-22 | Warnings | bc60460c-202e-434d-958d-98e30eb98cd1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.