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).
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| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50051-0002-4 | 2019-11-13 | C162847 | 48780-1 | 97449f38-ba47-f6ea-e053-dbdaa90aa703 | Flounder Sun Smacker SPF 24 Watermelon Wave |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50051-0002-4 | Flounder Sun Smacker SPF 24 Watermelon Wave | 4 g in 1 CYLINDER | LIPSTICK | 4 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50051-0002 | FLOUNDER SUN SMACKER SPF 24 WATERMELON WAVE (OCTINOXATE, OXYBENZONE, PADIMATE O) LIPSTICK [BONNE BELL LLC] | 2 | Legacy NDC, 1 package rows | 20120907_0d2f4af8-6c1a-47c2-983d-a34000e047be.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 |
|---|---|
| 50051-0002 | 50051-0002-4 |
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 |
|---|---|---|---|---|---|---|
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRACAVITARY | 0.01 ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SUSPENSION / AURICULAR (OTIC) | 0.02 %w/w | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | AEROSOL, FOAM / TOPICAL | 14235 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRALESIONAL | 20 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE, EXTENDED RELEASE / ORAL | 101 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | SPRAY / NASAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCUTANEOUS | 90 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 8.4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO, SUSPENSION / TOPICAL | 0.25 %w/v | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | ELIXIR / ORAL | 0.15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION, SOLUTION / INTRAMUSCULAR | 525 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, COATED / ORAL | 0.07 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INFILTRATION | 0.02 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / AURICULAR (OTIC) | 0.2 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CAPSULE, EXTENDED RELEASE / ORAL | 1.23 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| BENZYL BENZOATE | BENZYL BENZOATE | N863NB338G | SOLUTION / INTRAMUSCULAR | 447 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRA-ARTICULAR | 23 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CAPSULE / ORAL | 450 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | LOTION / TOPICAL | 50 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, SUGAR COATED / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING / ORAL | 83 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / VAGINAL | 0.49 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SUBCUTANEOUS | 28 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| CINNAMALDEHYDE | CINNAMALDEHYDE | SR60A3XG0F | SUSPENSION / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 36b6d2c0-b068-491b-87d0-529fb985ff57 | 0d2f4af8-6c1a-47c2-983d-a34000e047be | 2012-09-06 | Warnings | 36b6d2c0-b068-491b-87d0-529fb985ff57 0d2f4af8-6c1a-47c2-983d-a34000e047be |
Adverse event summaries are temporarily unavailable. Other product information remains available.