Dosage and administration
apply liberally before sun exposure and as needed children under 6 months of age: ask doctor
apply liberally before sun exposure and as needed children under 6 months of age: ask doctor
Active Ingredients Purpose
Octinoxate 7.5% Sunscreen
Oxybenzone 6% Sunscreen
Warnings
For external use only
When using this product keep out of eyes. Rinse with water remove.
Stop use and ask a doctor if rash and irritation develops and lasts
Keep out of reach of children. If swallowed get medical help or contact Poison Control right away.
Other information
Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin cancer, and other harmful effects of the sun.
Inactive Ingredients: Hydrogenated Coconut Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Olea Europaea (Olive) Fruit Oil, Flavor, Tocopheryl Acetate, Ammonium Glycyrrhizate, Glycine Soja (Soybean) Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Lecithin, Rosmarinus Officinalis (Rosemary) Leaf Extract.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51514-0217-1 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b7fb-f6ea-e053-dbdaa90aa703 | Drug facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51514-0217-1 | GAP Favorite Lip Balm Berry Punch SPF 18 | 4 g in 1 CONTAINER | STICK | 4 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51514-0217 | GAP FAVORITE LIP BALM BERRY PUNCH SPF 18 (OCTINOXATE AND OXYBEZONE) STICK [AUTUMN HARP, INC] | 1 | Legacy NDC, 1 package rows | 20111129_520d4dab-e149-4204-80a7-7f9d6cfe2924.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| AMMONIUM GLYCYRRHIZATE | INACTIVE INGREDIENT | 3VRD35U26C | 1 | |
| CALENDULA OFFICINALIS FLOWER | INACTIVE INGREDIENT | P0M7O4Y7YD | 1 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 1 | |
| ECHINACEA, UNSPECIFIED | INACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| HYDROGENATED COCONUT OIL | INACTIVE INGREDIENT | JY81OXM1OM | 1 | |
| OLIVE OIL | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| ROSEMARY | INACTIVE INGREDIENT | IJ67X351P9 | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51514-0217 | 51514-0217-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| HYDROGENATED COCONUT OIL | JY81OXM1OM | IACT |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| CANDELILLA WAX | WL0328HX19 | IACT |
| CALENDULA OFFICINALIS FLOWER | P0M7O4Y7YD | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| ALPHA-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| ROSEMARY | IJ67X351P9 | IACT |
| ECHINACEA, UNSPECIFIED | 4N9P6CC1DX | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | 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 | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| HYDROGENATED COCONUT OIL | HYDROGENATED COCONUT OIL | JY81OXM1OM | SUPPOSITORY / RECTAL | NA | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / ORAL | 425 mg/1ml | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET / ORAL | 4 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOAP / TOPICAL | NA | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, EXTENDED RELEASE / ORAL | 3 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | LOTION / TOPICAL | 32468 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / TOPICAL | 0.6 %w/w | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, FILM COATED / ORAL | 0.8 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | CAPSULE / ORAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, DELAYED RELEASE / ORAL | 1 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 |
|---|---|---|---|---|---|---|
| ec87de8a-37d4-4074-8538-e721380ee5b4 | 520d4dab-e149-4204-80a7-7f9d6cfe2924 | 2011-11-21 | Warnings | ec87de8a-37d4-4074-8538-e721380ee5b4 520d4dab-e149-4204-80a7-7f9d6cfe2924 |
Adverse event summaries are temporarily unavailable. Other product information remains available.