Dosage and administration
Apply generously and evenly 30 minutes before sun exposure. Reapply frequently and after swimming, excessive perspiration and towel drying.
Apply generously and evenly 30 minutes before sun exposure. Reapply frequently and after swimming, excessive perspiration and towel drying.
Homosalate 10.0%
Octisalate 5.0%
Avobenzone 2.0%
Octocrylene 2.0%
Oxybenzone 2.0%
FOR EXTERNAL USE ONLY.
Avoid contact with eyes. Rinse with water if contact occurs.
Discontinue use if signs of rash or irritation develop.
For use on children under the age of 6 months consult a physician.
Keep out of reach of children.
Apply generously and evenly 30 minutes before sun exposure. Reapply frequently and after swimming, excessive perspiration and towel drying.
This formula provides Broad Spectrum UVA/UVB protection from the sun's damaging rays. It is PABA free, vitamin enriched and very water resistant.
Water, Sorbitan Isostearate, Sorbitol, Polyglyceryl-3 Distearate, Triethanolamine, Stearic Acid, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Barium Sulfate, Carbomer, Simmondsia Chinensis (jojoba) Seed Oil, Tocopherol, Mineral Oil, Disodium EDTA, Aloe Barbadensis Leaf Juice, Octadecene/MA Co polymer, MethylParaben, Propylparaben, Fragrance.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1 | Product name | 1 | 20201123 |
| 85bed648-23ca-4804-98e6-e36aee999cad | Product name | 1 | 20190717 |
| 80de93b4-8a94-428d-beb7-d644353ee70b | Product name | 1 | 20180424 |
| eb4f7d5b-1286-40dc-b8bf-ad87ff51c688 | Product name | 1 | 20170522 |
| db8eb201-78c7-4590-8a71-fac0a539bd8c | Product name | 1 | 20170404 |
| 141092be-5eb5-452e-9f69-2d350aa70a87 | Product name | 1 | 20161208 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10056-705-56 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-12a6-f424-e053-dadaa90a57ce | 87db249b-db5a-49ce-a649-68024a02040d |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10056-705-56 | Peter Island SunscreenSPF 30 | 226 g in 1 BOTTLE, PLASTIC | LOTION | 226 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10056-705 | PETER ISLAND SUNSCREEN SPF 30 (HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [ACCESS BUSINESS GROUP LLC] | 1 | Legacy NDC, 1 package rows | 20130708_87db249b-db5a-49ce-a649-68024a02040d.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| BARIUM SULFATE | INACTIVE INGREDIENT | 25BB7EKE2E | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SORBITAN ISOSTEARATE | INACTIVE INGREDIENT | 01S2G2C1E4 | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10056-705 | 10056-705-56 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HOMOSALATE | V06SV4M95S | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| WATER | 059QF0KO0R | IACT |
| SORBITAN ISOSTEARATE | 01S2G2C1E4 | IACT |
| SORBITOL | 506T60A25R | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| BARIUM SULFATE | 25BB7EKE2E | IACT |
| JOJOBA OIL | 724GKU717M | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
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 |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRA-ARTICULAR | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / RECTAL | 124 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCUTANEOUS | 90 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAVENOUS | 0.13 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TRANSDERMAL | 14 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRA-ARTICULAR | 23 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / TOPICAL | 185 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAVENOUS | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUPPOSITORY / RECTAL | 129 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / SUBCUTANEOUS | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | LOTION / TOPICAL | 4000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %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 |
|---|---|---|---|---|---|---|
| 295f3a7c-6aaa-4590-beb9-2aa29f2149cf | 87db249b-db5a-49ce-a649-68024a02040d | 2013-06-28 | Warnings | 295f3a7c-6aaa-4590-beb9-2aa29f2149cf 87db249b-db5a-49ce-a649-68024a02040d |
Adverse event summaries are temporarily unavailable. Other product information remains available.