Indications and uses
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), helps decrease 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 ), helps decrease the risk of skin cancer and early skin aging caused by the sun.
Apply liberally 30 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 help 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 sun, ...
Protect this product from excessive heat and direct sun.
Drug Facts
Avobenzone 3.0%
Octinoxate 7.5%
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 swallowed, get medical help or contact a Poison Control Center right away.
Water/Aqua/Eau, Butylene Glycol, C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Cyclopentasiloxane, Aluminum Starch Octenylsuccinate, Cetearyl Phosphate, Polyglyceryl-2 Stearate, Dimethyl Capramide, VP/Eicosene Copolymer, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl, Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.
Call toll free
1-800-831-5150 in the US
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68479-012-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0306-f424-e053-dadaa90a57ce | Protection 50 Sport |
| 68479-012-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0306-f424-e053-dadaa90a57ce | Protection 50 Sport |
| 68479-012-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0306-f424-e053-dadaa90a57ce | Protection 50 Sport |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68479-012-00 | Protection 50 Sport | 2 mL in 1 POUCH | LOTION | 2 | 1 | |
| 68479-012-01 | Protection 50 Sport | 22 mL in 1 TUBE | LOTION | 22 | 1 | |
| 68479-012-02 | Protection 50 Sport | 156 mL in 1 TUBE | LOTION | 156 | 1 | |
| 68479-012-02 | Protection 50 Sport | 1 in 1 CARTON | LOTION | 1 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Alkyl (C12-15) Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| Aluminum Starch Octenylsuccinate | INACTIVE INGREDIENT | I9PJ0O6294 | 1 | |
| Arachidyl Alcohol | INACTIVE INGREDIENT | 1QR1QRA9BU | 1 | |
| Arachidyl Glucoside | INACTIVE INGREDIENT | 6JVW35JOOJ | 1 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) | INACTIVE INGREDIENT | 59TL3WG5CO | 1 | |
| Carthamus Tinctorius Seed Oleosomes | INACTIVE INGREDIENT | 9S60Q72309 | 1 | |
| Cetearyl Phosphate | INACTIVE INGREDIENT | 4O6GCK4CTJ | 1 | |
| Cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| Dimethyl Capramide | INACTIVE INGREDIENT | O29Y6X2JEZ | 1 | |
| Docosanol | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Eicosyl Povidone | INACTIVE INGREDIENT | XQQ9MKE2BJ | 1 | |
| Ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| Glycyrrhizinate Dipotassium | INACTIVE INGREDIENT | CA2Y0FE3FX | 1 | |
| Hyaluronate Sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68479-012 | 68479-012-02, 68479-012-01, 68479-012-00 |
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 |
|---|---|---|---|---|---|---|
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION, CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | ELIXIR / ORAL | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATHECAL | 176 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / VAGINAL | 20 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | DISC / TOPICAL | ADJ PH | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RECTAL | 97 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRA-ARTICULAR | 1 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | JELLY / TOPICAL | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SYRUP / ORAL | 71 mg/5ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / NASAL | 100 mg/100ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETHRAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-AMNIOTIC | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRATHECAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, EMULSION / INTRAVENOUS | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBCONJUNCTIVAL | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRASYNOVIAL | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVASCULAR | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAOCULAR | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACARDIAC | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RESPIRATORY (INHALATION) | 8 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LOTION / TOPICAL | 21 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTERSTITIAL | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / VAGINAL | 0.19 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / PARENTERAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRA-ARTICULAR | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / ORAL | 2 mg/5ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CONCENTRATE / ORAL | 10 mg/5ml |
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 |
|---|---|---|---|---|---|---|
| bce11406-0a51-4457-8f26-aa0360f752ff | a670e9bb-ceb3-4ef9-bf7d-546da8680478 | 2015-11-12 | Warnings | bce11406-0a51-4457-8f26-aa0360f752ff a670e9bb-ceb3-4ef9-bf7d-546da8680478 |
Adverse event summaries are temporarily unavailable. Other product information remains available.