Indications and uses
HELPS PREVENT SUNBURN HIGHER SPF GIVES MORE SUNBURN PROTECTION
HELPS PREVENT SUNBURN HIGHER SPF GIVES MORE SUNBURN PROTECTION
APPLY LIBERALLY 20 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED FOR CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR
AVOBENZONE 3.00%, HOMOSALATE 15.00%, OCTISALATE 5.00%, OCTOCRYLENE 10.00%, OXYBENZONE 6.00%
SUNSCREEN
FOR EXTERNAL USE ONLY
STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS OR LASTS
Limiting sun exposure, wearing protective clothing and using sunscreen reduces the risk of skin aging, skin cancer and other harmful effects of the sun.
BEESWAX, LAURYL LAURATE, OZOKERITE, CETEARYL BEHENATE, POLYBUTENE, CETYL ALCOHOL, STYRENE/ACRYLATES COPOLYMER, MYRISTYL MYRISTATE, TOCOPHEROL, COCOA SEED BUTTER, PHENOXYETHANOL, RETINYL PALMITATE, TETRAHEXYDECYL ASCORBATE
SPF55StickLabel.jpg
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51401-002-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bfbf-f424-e053-dadaa90a57ce | SKIN STRONG SKIN EQUIPMENT - SPF 55 SUNSCREEN STICK - DRUG FACTS LABEL |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51401-002-01 | SKIN STRONG - SKIN EQUIPMENTSPF 55 SUNSCREEN | 13.3 g in 1 APPLICATOR | STICK | 13.3 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51401-002 | SKIN STRONG - SKIN EQUIPMENT SPF 55 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) STICK [TRUE BALANCE ATHLETICS LLC] | 2 | Legacy NDC, 1 package rows | 20121222_b61987db-ef99-48b4-9be0-60555a8fcabb.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 2 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 2 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 2 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 2 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 2 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 2 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| CERESIN | INACTIVE INGREDIENT | Q1LS2UJO3A | 2 | |
| CETEARYL BEHENATE | INACTIVE INGREDIENT | 7ARI9LTH0U | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| COCOA BUTTER | INACTIVE INGREDIENT | 512OYT1CRR | 2 | |
| LAURYL LAURATE | INACTIVE INGREDIENT | GPW77G0937 | 2 | |
| MYRISTYL MYRISTATE | INACTIVE INGREDIENT | 4042ZC00DY | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYBUTENE (1400 MW) | INACTIVE INGREDIENT | 1NA5AO9GH7 | 2 | |
| TETRAHEXYLDECYL ASCORBATE | INACTIVE INGREDIENT | 9LBV3F07AZ | 2 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 2 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 2 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51401-002 | 51401-002-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AVOBENZONE | G63QQF2NOX | ACTIB |
| HOMOSALATE | V06SV4M95S | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| LAURYL LAURATE | GPW77G0937 | IACT |
| CERESIN | Q1LS2UJO3A | IACT |
| CETEARYL BEHENATE | 7ARI9LTH0U | IACT |
| POLYBUTENE (1400 MW) | 1NA5AO9GH7 | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| MYRISTYL MYRISTATE | 4042ZC00DY | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| COCOA BUTTER | 512OYT1CRR | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| VITAMIN A PALMITATE | 1D1K0N0VVC | IACT |
| TETRAHEXYLDECYL ASCORBATE | 9LBV3F07AZ | 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 |
|---|---|---|---|---|---|---|
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | INJECTION, EMULSION / INTRAVENOUS | 0.02 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| CERESIN | CERESIN | Q1LS2UJO3A | OINTMENT / TOPICAL | 1097 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CAPSULE, DELAYED RELEASE / ORAL | 59 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| CERESIN | CERESIN | Q1LS2UJO3A | CREAM / VAGINAL | 280 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / RECTAL | 17 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, EXTENDED RELEASE / ORAL | 132 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | EMULSION / TOPICAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET / ORAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| POLYBUTENE (1400 MW) | POLYBUTENE (1400 MW) | 1NA5AO9GH7 | SYSTEM / TRANSDERMAL | 17.87 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| POLYBUTENE (1400 MW) | POLYBUTENE (1400 MW) | 1NA5AO9GH7 | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| COCOA BUTTER | COCOA BUTTER | 512OYT1CRR | SUPPOSITORY / RECTAL | 2280 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, ORALLY DISINTEGRATING / ORAL | 9 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 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 |
|---|---|---|---|---|---|---|
| c536b73e-65b8-4dae-9e44-32124e551aab | b61987db-ef99-48b4-9be0-60555a8fcabb | 2012-12-19 | Warnings | c536b73e-65b8-4dae-9e44-32124e551aab b61987db-ef99-48b4-9be0-60555a8fcabb |
Adverse event summaries are temporarily unavailable. Other product information remains available.