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 reapply: after 80 minutes of swimming or sweating immediately after towel drying 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 15 or higher and other sun protection measures including: limit time in the sun, esp...
Drug Facts
Octocrylene 5.0%
Octisalate 5.0%
Oxybenzone 4.0%
Avobenzone 2.0%
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.
deionized water, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), cetyl dimethicone, aloe barbadensis leaf extract, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol (vegetable derived), methylparaben, diazolidinyl urea and propylparaben.
Call toll free 1-800-368-7327
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52854-255-01 | 2022-11-29 | C162847 | 48780-1 | d6a99b39-d505-a426-e053-dadaa90af4c2 | 0747a9c8-2d30-4507-92c4-da30c8df0bbe |
| 52854-255-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d505-a426-e053-dadaa90af4c2 | 0747a9c8-2d30-4507-92c4-da30c8df0bbe |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| octocrylene | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| octocrylene | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| aloe vera leaf | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| carbomer copolymer type b (allyl pentaerythritol crosslinked) | INACTIVE INGREDIENT | 809Y72KV36 | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| cetyl dimethicone 150 | INACTIVE INGREDIENT | 5L694Y0T22 | 1 | |
| diazolidinyl urea | INACTIVE INGREDIENT | H5RIZ3MPW4 | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl stearate se | INACTIVE INGREDIENT | FCZ5MH785I | 1 | |
| high density polyethylene | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| phenethyl benzoate | INACTIVE INGREDIENT | 0C143929GK | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| tricontanyl povidone (4 tricontanyl branches/repeat) | INACTIVE INGREDIENT | N0SS3Q238D | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52854-255 | 52854-255-01 |
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 |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| glyceryl stearate se | GLYCERYL STEARATE SE | FCZ5MH785I | CREAM / TOPICAL | 4 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / ORAL | 11 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERINEURAL | ADJ PH | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED / ORAL | 0.08 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET, ORALLY DISINTEGRATING / ORAL | 9 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | TABLET, COATED / ORAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 5.4 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION, CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / TOPICAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRATHECAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INFILTRATION | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | PASTE / DENTAL | 0.6 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTERSTITIAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 7.01 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, LIQUID FILLED / ORAL | 1.5 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INFILTRATION | ADJ PH | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| carbomer copolymer type b (allyl pentaerythritol crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | LOTION / TOPICAL | 29 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| high density polyethylene | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | SUPPOSITORY / RECTAL | NA | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | ELIXIR / ORAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | DROPS / OPHTHALMIC | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | CAPSULE, DELAYED RELEASE / ORAL | 59 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER / RESPIRATORY (INHALATION) | ADJ PH | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | SPRAY / TOPICAL | 1 %w/w |
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 |
|---|---|---|---|---|---|---|
| eea1247f-a64d-57e7-e053-2a95a90ad586 | 0747a9c8-2d30-4507-92c4-da30c8df0bbe | 2022-11-29 | Warnings | 0747a9c8-2d30-4507-92c4-da30c8df0bbe |
Adverse event summaries are temporarily unavailable. Other product information remains available.