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 generously and evenly 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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 value of 15 or higher and other sun protection measures including: l...
protect the product in this container from excessive heat and direct sun
Drug Facts
| Active ingredients | Purpose |
|---|---|
| octinoxate 7.50% | Sunscreen |
| octocrylene 1.00% | Sunscreen |
| titanium dioxide 3.00% | 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:
mica • lauroyl lysine • cellulose acetate • dimethicone • ascorbyl palmitate • rosmarinus officinalis (rosemary) extract • punica granatum (pomegranate) juice extract • sanguisorba officinalis (burnet) root extract • curcuma longa (turmeric) root extract • caprylyl methicone • methicone • ethylhexylglycerin • caffeine • oryzanol • isostearyl sebacate • disodium stearoyl glutamate • pentylene glycol • zinc myristate • silica • glycyrrhetinic acid • alumina • citrus aurantifolia (lime) oil1, citrus grandis (grapefruit) peel oil1, cymbopogon schoenanthus (lemongrass) oil1, mentha viridis (spearmint) leaf oil1, salvia sclarea (clary sage) oil1, ormenis multicaulis (chamomile) oil1, pelargonium graveolens (geranium) flower oil1, lavandula angustifolia (lavender) oil1, thymus vulgaris (thyme) oil1, coriandrum sativum (coriander) fruit oil1, limonene, linalool • phenoxyethanol • [+/- iron oxides (ci 77491, ci 77492, ci 77499) • titanium dioxide (ci 77891)] <iln37037>
1 essential oil
protect the product in this container from excessive heat and direct sun
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| ascorbyl palmitate | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| caffeine | INACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| caprylyl trisiloxane | INACTIVE INGREDIENT | Q95M2P1KJL | 1 | |
| cellulose acetate | INACTIVE INGREDIENT | 3J2P07GVB6 | 1 | |
| citrus maxima fruit rind oil | INACTIVE INGREDIENT | 8U3877WD44 | 1 | |
| clary sage oil | INACTIVE INGREDIENT | 87L0D4U3M0 | 1 | |
| coriander oil | INACTIVE INGREDIENT | 7626GC95E5 | 1 | |
| cymbopogon schoenanthus oil | INACTIVE INGREDIENT | XE7K568ILO | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| disodium stearoyl glutamate | INACTIVE INGREDIENT | 45ASM2L11M | 1 | |
| enoxolone | INACTIVE INGREDIENT | P540XA09DR | 1 | |
| ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| gamma oryzanol | INACTIVE INGREDIENT | SST9XCL51M | 1 | |
| lauroyl lysine | INACTIVE INGREDIENT | 113171Q70B | 1 | |
| lavender oil | INACTIVE INGREDIENT | ZBP1YXW0H8 | 1 | |
| lime oil | INACTIVE INGREDIENT | UZH29XGA8G | 1 | |
| linalool, (+/-)- | INACTIVE INGREDIENT | D81QY6I88E | 1 | |
| mica | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| pelargonium graveolens flower oil | INACTIVE INGREDIENT | 3K0J1S7QGC | 1 | |
| pentylene glycol | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| pomegranate juice | INACTIVE INGREDIENT | 99S671U9KB | 1 | |
| rosemary | INACTIVE INGREDIENT | IJ67X351P9 | 1 | |
| sanguisorba officinalis root | INACTIVE INGREDIENT | 4NYV2HT01X | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| spearmint oil | INACTIVE INGREDIENT | C3M81465G5 | 1 | |
| thyme oil | INACTIVE INGREDIENT | 2UK410MY6B | 1 | |
| turmeric | INACTIVE INGREDIENT | 856YO1Z64F | 1 | |
| zinc myristate | INACTIVE INGREDIENT | K09A9E2GGO | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59427-009 | 59427-009-01 |
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 |
|---|---|---|---|---|---|---|
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| ferrosoferric oxide | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| spearmint oil | SPEARMINT OIL | C3M81465G5 | SYRUP / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| ferrosoferric oxide | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| spearmint oil | SPEARMINT OIL | C3M81465G5 | OINTMENT / TOPICAL | NA | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| lavender oil | LAVENDER OIL | ZBP1YXW0H8 | INHALANT / NASAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| ascorbyl palmitate | ASCORBYL PALMITATE | QN83US2B0N | TABLET / ORAL | 7.14 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| ascorbyl palmitate | ASCORBYL PALMITATE | QN83US2B0N | CREAM / TOPICAL | 0.02 %w/w | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| ferrosoferric oxide | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| cellulose acetate | CELLULOSE ACETATE | 3J2P07GVB6 | CAPSULE / ORAL | 186 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| caffeine | CAFFEINE | 3G6A5W338E | SPRAY, METERED / NASAL | 10 mg/1ml | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| ferrosoferric oxide | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| ferrosoferric oxide | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| coriander oil | CORIANDER OIL | 7626GC95E5 | LIQUID / ORAL | 2.5 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| ferrosoferric oxide | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| ascorbyl palmitate | ASCORBYL PALMITATE | QN83US2B0N | SYSTEM / TOPICAL | 0.04 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 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 |
|---|---|---|---|---|---|---|
| 8b7d20ee-8b78-4fd2-8256-9342b36eb0d0 | 4f83c72e-00b5-404f-bc46-c5e0635596e7 | 2021-07-14 | Warnings | 4f83c72e-00b5-404f-bc46-c5e0635596e7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.