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.
apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months of age: Ask a doctor 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: limit time in ...
Drug Facts
Octinoxate 5%
Titanium Dioxide 10%
Sunscreen
For external use only
Do not use on damaged or broken skin.
When using this product keep out of the eyes. Rinse with water to remove.
Stop use and ask a doctor if skin rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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:
Aqua (Water/Eau), Ethylhexyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Silica, Cyclopentasiloxane, Caprylic/Capric Triglyceride, HDI/Trimethylol Hexyllactone Crosspolymer, Butylene Glycol, Glycerin, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Octyldodecanol, Octyldecyl Xyloside, PEG-30 Dipolyhydroxystearate, Silica Dimethyl Silylate, Phenoxyethanol, Hydroxyethylacrylate/Sodium Acryloydimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Caprylyl Glycol, Ethylhexyl Glycerin, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Polymethylsilsesquioxane, Dimethicone, Retinyl Palmitate (Vitamin A), Triethoxycaprylylsilane, Camellia Oleifera (Green Tea) Leaf Extract, Diamond Powder, (+/-):Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)
Call: 1.800.232.0398 M-F 9am-6pm MST
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 60541-8407-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-715f-f424-e053-dadaa90a57ce | 3a4e17fb-22c8-4c79-a140-17000ff13802 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60541-8407-4 | Octinoxate | 30 mL in 1 BOTTLE | LOTION | 30 | 2 | |
| 60541-8407-4 | Octinoxate | 1 in 1 BOX | LOTION | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60541-8407 | OCTINOXATE LOTION [HAYDEN CALEEL LLC] | 2 | Legacy NDC, 2 package rows | 20150522_3a4e17fb-22c8-4c79-a140-17000ff13802.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| .Alpha.-Tocopherol Acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 2 | |
| Camellia Oleifera Leaf | INACTIVE INGREDIENT | 5077EL0C60 | 2 | |
| Caprylyl Glycol | INACTIVE INGREDIENT | 00YIU5438U | 2 | |
| Cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 2 | |
| Cyclomethicone 6 | INACTIVE INGREDIENT | XHK3U310BA | 2 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| Ethylhexyl Palmitate | INACTIVE INGREDIENT | 2865993309 | 2 | |
| Ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 2 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| Hexylene Glycol | INACTIVE INGREDIENT | KEH0A3F75J | 2 | |
| Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.S At 1%) | INACTIVE INGREDIENT | 86FQE96TZ4 | 2 | |
| Isohexadecane | INACTIVE INGREDIENT | 918X1OUF1E | 2 | |
| Medium-Chain Triglycerides | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| Neopentyl Glycol Dicaprylate/Dicaprate | INACTIVE INGREDIENT | VLW429K27K | 2 | |
| Octyldodecanol | INACTIVE INGREDIENT | 461N1O614Y | 2 | |
| Peg-30 Dipolyhydroxystearate | INACTIVE INGREDIENT | 9713Q0S7FO | 2 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| Polyglyceryl-3 Diisostearate | INACTIVE INGREDIENT | 46P231IQV8 | 2 | |
| Polymethylsilsesquioxane (4.5 Microns) | INACTIVE INGREDIENT | 59Z907ZB69 | 2 | |
| Polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 2 | |
| Silica Dimethyl Silylate | INACTIVE INGREDIENT | EU2PSP0G0W | 2 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| Tetrahexyldecyl Ascorbate | INACTIVE INGREDIENT | 9LBV3F07AZ | 2 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| Tridecyl Trimellitate | INACTIVE INGREDIENT | FY36J270ES | 2 | |
| Triethoxycaprylylsilane | INACTIVE INGREDIENT | LDC331P08E | 2 | |
| Vitamin A Palmitate | INACTIVE INGREDIENT | 1D1K0N0VVC | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 60541-8407 | 60541-8407-4 |
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 |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| Silica Dimethyl Silylate | SILICA DIMETHYL SILYLATE | EU2PSP0G0W | TABLET / ORAL | 8 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| .Alpha.-Tocopherol Acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| Butylene Glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | EMULSION / ORAL | 20 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | OINTMENT / TOPICAL | 20 %w/w | ||
| Cyclomethicone 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| Silica Dimethyl Silylate | SILICA DIMETHYL SILYLATE | EU2PSP0G0W | SUSPENSION / ORAL | 120 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / RECTAL | 0.05 mg/mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Octyldodecanol | OCTYLDODECANOL | 461N1O614Y | GEL / TOPICAL | 10 %w/w | ||
| Octyldodecanol | OCTYLDODECANOL | 461N1O614Y | CREAM / VAGINAL | 13.5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| Silica Dimethyl Silylate | SILICA DIMETHYL SILYLATE | EU2PSP0G0W | CAPSULE / ORAL | 0.5 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 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 |
|---|---|---|---|---|---|---|
| 332c5fb6-263c-4b12-b37b-59a80c19c71e | 3a4e17fb-22c8-4c79-a140-17000ff13802 | 2013-08-27 | Warnings | 332c5fb6-263c-4b12-b37b-59a80c19c71e 3a4e17fb-22c8-4c79-a140-17000ff13802 |
Adverse event summaries are temporarily unavailable. Other product information remains available.