OTC - ACTIVE INGREDIENT SECTION
Ensulizole 3%
Homosalate 10%
Octinoxate 7.5%
Octocrylene 7%
Zinc oxide 8%
Ensulizole 3%
Homosalate 10%
Octinoxate 7.5%
Octocrylene 7%
Zinc oxide 8%
A hydrating, broad spectrum UVA/UVB sunscreen, which provides protection against sunburn. Combines our moisturizing Bio-MapleTM compound with a mixture of sunscreens that protect skin by scattering, reflecting and absorbing harmful sun rays. Fragrance, color and oil-free, ideal for those with sensitive skin.
Uses
■ Helps prevent sunburn.
■ Higher SPF gives more sunburn protection.
■ Provides high protection against sunburn.
Warnings
For external use only.
Avoid contact with eyes when using this product. If contact occurs, rinse abundantly with water to remove.
Discontinue
use in case of excessive skin irritation or if condition does not
improve. If irritation persists, consult a health care practitioner.
If swallowed, seek medical assistance or contact a Poison Control
Center immediately.
Other information
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.Store at room temperature 15-30°C (59-86°F).
■ Reapply every two hours or as needed.
■ Reapply
after swimming, towel drying, washing or perspiring heavily.
■ Consult a doctor before using on children under six months of age.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63550-852-10 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c67d-8e05-e053-dbdaa90a074a | SUN DEFENSE UVscreen SPF48 CONSUMER LABELING |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63550-852-10 | Sun Defense UVscreen SPF 48 | 120 mL in 1 BOX | CREAM | 120 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ENSULIZOLE | ACTIVE INGREDIENT | 9YQ9DI1W42 | 1 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| ENSULIZOLE | ACTIVE MOIETY | 9YQ9DI1W42 | 1 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, D- | INACTIVE INGREDIENT | A7E6112E4N | 1 | |
| ACER SACCHARUM SAP | INACTIVE INGREDIENT | 75UOH57984 | 1 | |
| C13-14 ISOPARAFFIN | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| CYCLOMETHICONE 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | 1 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| STEARETH-100 | INACTIVE INGREDIENT | 4OH5W9UM87 | 1 | |
| STEARETH-2 | INACTIVE INGREDIENT | V56DFE46J5 | 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 |
|---|---|
| 63550-852 | 63550-852-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ENSULIZOLE | 9YQ9DI1W42 | ACTIB |
| HOMOSALATE | V06SV4M95S | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| WATER | 059QF0KO0R | IACT |
| CYCLOMETHICONE 5 | 0THT5PCI0R | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| ACER SACCHARUM SAP | 75UOH57984 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CYCLOMETHICONE 6 | XHK3U310BA | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| STEARETH-100 | 4OH5W9UM87 | IACT |
| C13-14 ISOPARAFFIN | E4F12ROE70 | IACT |
| LAURETH-7 | Z95S6G8201 | IACT |
| STEARETH-2 | V56DFE46J5 | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| .ALPHA.-TOCOPHEROL ACETATE, D- | A7E6112E4N | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| CHLORPHENESIN | I670DAL4SZ | 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 |
|---|---|---|---|---|---|---|
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-AMNIOTIC | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / NASAL | 20 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERIDURAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / ORAL | 11 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| STEARETH-100 | STEARETH-100 | 4OH5W9UM87 | OINTMENT / TOPICAL | 86 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | INJECTION / SUBCUTANEOUS | 10 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | INJECTION / INTRAVENOUS | 2232 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / RETROBULBAR | ADJ PH | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PARENTERAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRATHECAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAMUSCULAR | 78 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / PARENTERAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, METERED / RESPIRATORY (INHALATION) | ADJ PH | ||
| STEARETH-2 | STEARETH-2 | V56DFE46J5 | LOTION / TOPICAL | 0.4 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | FILM / BUCCAL | 0.09 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBCUTANEOUS | 31.45 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBMUCOSAL | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LOTION, AUGMENTED / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR | ADJ PH | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | SUPPOSITORY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SOFT TISSUE | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / PERIODONTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / OPHTHALMIC | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVENOUS | 78 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAVENOUS | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | INJECTION / INTRACARDIAC | 0.01 %w/v | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 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 |
|---|---|---|---|---|---|---|
| 54f7851c-d8e2-45a0-847d-e49cd78c6661 | 8326d76e-c1de-498e-abe5-9ecae4e9e6d4 | 2011-09-02 | Warnings | 54f7851c-d8e2-45a0-847d-e49cd78c6661 8326d76e-c1de-498e-abe5-9ecae4e9e6d4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.