Indications and uses
helps prevent sunburn helps prevent chapped or cracked skin 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 helps prevent chapped or cracked skin 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 3.0%
Avobenzone 2.5%
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 product is swallowed, get medical help or contact a Poison Control Center right away.
ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.
Call toll free 1-800-368-7327
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52854-796-85 | 2022-11-29 | C162847 | 48780-1 | d6a99b39-a199-a426-e053-dadaa90af4c2 | e17b20c4-4702-4656-94e0-d5af772b482c |
| 52854-796-85 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a199-a426-e053-dadaa90af4c2 | e17b20c4-4702-4656-94e0-d5af772b482c |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| octocrylene | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| octocrylene | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| candelilla wax | INACTIVE INGREDIENT | WL0328HX19 | 1 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| castor oil | INACTIVE INGREDIENT | D5340Y2I9G | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| cetyl dimethicone 150 | INACTIVE INGREDIENT | 5L694Y0T22 | 1 | |
| coconut | INACTIVE INGREDIENT | 3RT3536DHY | 1 | |
| glyceryl stearate se | INACTIVE INGREDIENT | FCZ5MH785I | 1 | |
| hippophae rhamnoides seed oil | INACTIVE INGREDIENT | T53SBG6741 | 1 | |
| hydrogenated castor oil | INACTIVE INGREDIENT | ZF94AP8MEY | 1 | |
| hydrogenated soybean oil | INACTIVE INGREDIENT | A2M91M918C | 1 | |
| lauryl laurate | INACTIVE INGREDIENT | GPW77G0937 | 1 | |
| octyldodecyl neopentanoate | INACTIVE INGREDIENT | X8725R883T | 1 | |
| olive oil | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| phenethyl benzoate | INACTIVE INGREDIENT | 0C143929GK | 1 | |
| yellow wax | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52854-796 | 52854-796-85 |
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 |
|---|---|---|---|---|---|---|
| yellow wax | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| castor oil | CASTOR OIL | D5340Y2I9G | SOLUTION / TOPICAL | 1.38 %w/w | ||
| castor oil | CASTOR OIL | D5340Y2I9G | GEL / NASAL | 429 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | TABLET, EXTENDED RELEASE / ORAL | 23.27 mg | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | LIQUID / TOPICAL | 0.24 %w/w | ||
| castor oil | CASTOR OIL | D5340Y2I9G | TABLET / ORAL | 17 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | CAPSULE, EXTENDED RELEASE / ORAL | 47 mg | ||
| glyceryl stearate se | GLYCERYL STEARATE SE | FCZ5MH785I | LOTION / TOPICAL | 46 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | AEROSOL, FOAM / TOPICAL | 2 %w/w | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | CAPSULE / ORAL | 1.04 mg | ||
| olive oil | OLIVE OIL | 6UYK2W1W1E | SOAP / TOPICAL | NA | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET, DELAYED RELEASE / ORAL | 1337 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET / SUBLINGUAL | 1.6 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | SPRAY / NASAL | NA | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| candelilla wax | CANDELILLA WAX | WL0328HX19 | TABLET, EXTENDED RELEASE / ORAL | 3 mg | ||
| olive oil | OLIVE OIL | 6UYK2W1W1E | CAPSULE / ORAL | NA | ||
| candelilla wax | CANDELILLA WAX | WL0328HX19 | TABLET, DELAYED RELEASE / ORAL | 1 mg | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | OINTMENT / TOPICAL | 1.2 %w/w | ||
| castor oil | CASTOR OIL | D5340Y2I9G | INJECTION, SOLUTION / INTRAMUSCULAR | 525 mg | ||
| candelilla wax | CANDELILLA WAX | WL0328HX19 | TABLET / ORAL | 4 mg | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| glyceryl stearate se | GLYCERYL STEARATE SE | FCZ5MH785I | CREAM / TOPICAL | 4 %w/w | ||
| castor oil | CASTOR OIL | D5340Y2I9G | INJECTION / INTRAMUSCULAR | 885 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | OINTMENT / TOPICAL | 14.9 %w/w | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| olive oil | OLIVE OIL | 6UYK2W1W1E | SOLUTION / TOPICAL | 0.6 %w/w | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | SUPPOSITORY / VAGINAL | NA | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | GRANULE, FOR SUSPENSION / ORAL | 128 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| hydrogenated soybean oil | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | SUSPENSION / TOPICAL | 286 mg | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | TABLET / SUBLINGUAL | 1.6 mg | ||
| hydrogenated soybean oil | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET / ORAL | 13.5 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | LOTION / TOPICAL | 3627 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | CAPSULE, EXTENDED RELEASE / ORAL | 9.43 mg | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET, FILM COATED / ORAL | 17 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | TABLET, COATED / ORAL | 0.9 mg | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET, FOR SUSPENSION / ORAL | 17 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | EMULSION / OPHTHALMIC | 32 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | SPRAY / TOPICAL | 1 %w/w | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / VAGINAL | 6 mg | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET / ORAL | 232 mg | ||
| olive oil | OLIVE OIL | 6UYK2W1W1E | SOLUTION / ORAL | 425 mg/1ml | ||
| olive oil | OLIVE OIL | 6UYK2W1W1E | LOTION / TOPICAL | 32468 mg | ||
| hydrogenated castor oil | HYDROGENATED CASTOR OIL | ZF94AP8MEY | CAPSULE, EXTENDED RELEASE / ORAL | 410.82 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 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 |
|---|---|---|---|---|---|---|
| eea0eb16-d533-7c6e-e053-2a95a90a0241 | e17b20c4-4702-4656-94e0-d5af772b482c | 2022-11-29 | Warnings | e17b20c4-4702-4656-94e0-d5af772b482c |
Adverse event summaries are temporarily unavailable. Other product information remains available.