Dosage and administration
APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.
APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.
OCTINOXATE 7.5% W/W, OXYBENZONE 6.0% W/W, PADIMATE O 8.0% W/W.
SUNSCREEN
HELPS PREVENT SUNBURN
STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.
APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.
CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR.
LiP SMACKER (R)
Cool Strawberry Orange
DIST. ASPIRE BRANDS/BONNE BELL (R)
SANTA MONICA CA 90404
Made in U.S.A. net wt. 0.14 oz/4.0 g
SPF 24
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50051-0016-4 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d50b-cd31-e053-dbdaa90ab51a | Lip Smacker SPF 24 Cool Strawberry Orange |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50051-0016-4 | Lip Smacker SPF 24 Cool Strawberry Orange | 4 g in 1 CYLINDER | LIPSTICK | 4 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50051-0016 | LIP SMACKER SPF 24 COOL STRAWBERRY ORANGE (OCTINOXATE, OXYBENZONE) LIPSTICK [BONNE BELL LLC] | 2 | Legacy NDC, 1 package rows | 20121012_d2bf37db-0814-449d-b8b1-b5213aae376c.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 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CETYL ACETATE | INACTIVE INGREDIENT | 4Q43814HXS | 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 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 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 | |
| RICINUS COMMUNIS SEED | INACTIVE INGREDIENT | 7EK4SFN1TX | 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 |
|---|---|
| 50051-0016 | 50051-0016-4 |
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 |
|---|---|---|---|---|---|---|
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / VAGINAL | 50 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, FILM COATED / ORAL | 0.8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | SOAP / TOPICAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| D&C RED NO. 22 | D&C RED NO. 22 | 1678RKX8RT | TABLET, COATED / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAVENOUS | 396 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | OINTMENT / TOPICAL | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TOPICAL | 7 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE / ORAL | 1 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TRANSDERMAL | 85 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / VAGINAL | 0.49 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / RESPIRATORY (INHALATION) | 0.13 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / AURICULAR (OTIC) | 36 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 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 |
|---|---|---|---|---|---|---|
| 0bfe070d-bca0-47c0-9b7d-bd5524918de7 | d2bf37db-0814-449d-b8b1-b5213aae376c | 2012-10-11 | Warnings | 0bfe070d-bca0-47c0-9b7d-bd5524918de7 d2bf37db-0814-449d-b8b1-b5213aae376c |
Adverse event summaries are temporarily unavailable. Other product information remains available.