Dosage and administration
Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: Ask a doctor.
Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: Ask a doctor.
Protect this product from excessive heat and direct sun
Drug Facts
Octinoxate 7.5 percent w per w
Oxybenzone 6.0 percent w per w
Padimate 0 8.0 percent w per w
Sunscreen
HELPS PREVENT SUNBURN.
Skin Cancer Skin Aging Alert. Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
on damaged or broken skin
if rash occurs
keep out of eyes. Rinse with water to remove
If swallowed, get medical help or contact a Poison Control Center right away
Protect this product from excessive heat and direct sun
RICINUS COMMUNIS (CASTOR) SEED OIL, CETYL ACETATE, BEESWAX (CERA ALBA), EUPHORBIA CERIFERA (CANDELILLA) WAX, FLAVOR/AROMA, POLYBUTENE, COPERNICIA CERIFERA (CARNAUBA) WAX, OZOKERITE, ACETYLATED LANOLIN ALCOHOL, SESAMUM INDICUM (SESAME) SEED OIL, ISOPROPYL MYRISTATE, BENZYL BENZOATE, PARAFFIN, POLYESTER-3, TRITICUM VULGARE (WHEAT) GERM OIL, MICA, PROPYLENE GLYCOL, STEARIC ACID, HYDROGENATED SOY GLYCERIDES, PROPYL GALLATE, CITRIC ACID, NEOTAME, CITRAL, LINALOOL, BENZYL ALCOHOL, GERANIOL, METHYL 2-OCTYNOATE, CINNAMAL, EUGENOL, FARNESOL, LIMONENE. MAY CONTAIN (PLUS OR MINUS) TITANIUM DIOXIDE (CI 77891), BLUE 1 LAKE (CI 42090), RED 28 (CI 45410), RED 6 LAKE (CI 15850), RED 22 (CI 45380), YELLOW 5 LAKE (CI 19140), CARMINE (CI 75470).
Call 1-866-984-1433
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50051-0008-4 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b912-f6ea-e053-dbdaa90aa703 | Mickey Sun Smacker SPF 24 Classic Vanilla |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50051-0008-4 | Mickey Sun Smacker SPF 24 Classic Vanilla | 4 g in 1 CYLINDER | LIPSTICK | 4 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50051-0008 | MICKEY SUN SMACKER SPF 24 CLASSIC VANILLA (OCTINOXATE, OXYBENZONE, PADIMATE O) LIPSTICK [BONNE BELL LLC] | 2 | Legacy NDC, 1 package rows | 20120907_e982edde-2b68-4dc6-b9f7-ba0239dc84b3.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| PADIMATE O | ACTIVE INGREDIENT | Z11006CMUZ | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| PADIMATE O | ACTIVE MOIETY | Z11006CMUZ | 2 | |
| ACETYLATED LANOLIN ALCOHOLS | INACTIVE INGREDIENT | SNN716810P | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 2 | |
| BENZYL BENZOATE | INACTIVE INGREDIENT | N863NB338G | 2 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | 2 | |
| CETYL ACETATE | INACTIVE INGREDIENT | 4Q43814HXS | 2 | |
| CINNAMALDEHYDE | INACTIVE INGREDIENT | SR60A3XG0F | 2 | |
| CITRAL | INACTIVE INGREDIENT | T7EU0O9VPP | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 2 | |
| D&C RED NO. 22 | INACTIVE INGREDIENT | 1678RKX8RT | 2 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | 2 | |
| D&C RED NO. 6 | INACTIVE INGREDIENT | 481744AI4O | 2 | |
| EUGENOL | INACTIVE INGREDIENT | 3T8H1794QW | 2 | |
| FARNESOL | INACTIVE INGREDIENT | EB41QIU6JL | 2 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 2 | |
| GERANIOL | INACTIVE INGREDIENT | L837108USY | 2 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 2 | |
| LINALOOL, (+/-)- | INACTIVE INGREDIENT | D81QY6I88E | 2 | |
| METHYL HEPTINE CARBONATE | INACTIVE INGREDIENT | 0TTP6YT2T3 | 2 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 2 | |
| NEOTAME | INACTIVE INGREDIENT | VJ597D52EX | 2 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 2 | |
| PROPYL GALLATE | INACTIVE INGREDIENT | 8D4SNN7V92 | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SESAME OIL | INACTIVE INGREDIENT | QX10HYY4QV | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| WHEAT GERM OIL | INACTIVE INGREDIENT | 14C97E680P | 2 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50051-0008 | 50051-0008-4 |
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 |
|---|---|---|---|---|---|---|
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / RESPIRATORY (INHALATION) | 0.03 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAMUSCULAR | 225 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAMUSCULAR | 26 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAVENOUS | 400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, EXTENDED RELEASE / ORAL | 321 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM / TRANSDERMAL | 58.08 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | TABLET, COATED / ORAL | NA | ||
| BENZYL BENZOATE | BENZYL BENZOATE | N863NB338G | INJECTION, SOLUTION / INTRAMUSCULAR | 750 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | CREAM / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LOZENGE / BUCCAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | TABLET, DELAYED RELEASE / ORAL | 0.38 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / TOPICAL | 0.01 %w/v | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TRANSDERMAL | 85 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | AEROSOL / TOPICAL | NA | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CAPSULE, EXTENDED RELEASE / ORAL | 100 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | SOLUTION / TOPICAL | 1.38 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | TABLET, FILM COATED / ORAL | 0.04 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| SESAME OIL | SESAME OIL | QX10HYY4QV | INJECTION / INTRAMUSCULAR | 70 %v/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING / ORAL | 83 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAVENOUS | 45 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SUSPENSION / ORAL | 840 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, EXTENDED RELEASE / ORAL | 23.27 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / TOPICAL | 0.2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SUBCUTANEOUS | 28 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE, COATED PELLETS / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INHALANT / RESPIRATORY (INHALATION) | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml |
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 |
|---|---|---|---|---|---|---|
| 717b9d65-5755-4c18-b8aa-b8773c9bbac6 | e982edde-2b68-4dc6-b9f7-ba0239dc84b3 | 2012-09-06 | Warnings | 717b9d65-5755-4c18-b8aa-b8773c9bbac6 e982edde-2b68-4dc6-b9f7-ba0239dc84b3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.