OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
OCTINOXATE (%)
OXYBENZONE (4.5%)
ACTIVE INGREDIENTS:
OCTINOXATE (%)
OXYBENZONE (4.5%)
PURPOSE:
SUNSCREEN
INDICATIONS:
HELPS PREVENT SUNBURN.
DIRECTIONS:
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: ASK A DOCTOR.
KEEP OUT OF REACH OF CHILDREN.
WARNINGS:
FOR EXTERNAL USE ONLY. DO NOT USE ON DAMAGED OR BROKEN SKIN. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Other Ingredients:
ALOE BARBADENSIS LEAF JUICE, BEESWAX, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA (COCONUT) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED VEGETABLE OIL, LANOLIN, MANGIFERA INDICA (MANGO) SEED BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, RICINUS COMMUNIS (CASTOR) SEED OIL, TOCOPHEROL, TOCOPHERYL ACETATE (VITAMIN E)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61477-214-14 | 2022-04-16 | C162847 | 48780-1 | d6a99b39-d1d3-a426-e053-dadaa90af4c2 | ALOE UP - NATURAL LIP ICE SPF 15 (61477-214) |
| 61477-214-14 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d1d3-a426-e053-dadaa90af4c2 | ALOE UP - NATURAL LIP ICE SPF 15 (61477-214) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61477-214-14 | ALOE UP NATURAL LIP ICE SUNSCREEN | 4.25 g in 1 TUBE | LIPSTICK | 4.25 | 7 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| AVOCADO OIL | INACTIVE INGREDIENT | 6VNO72PFC1 | 2 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 2 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | 2 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | 2 | |
| HYDROGENATED SOYBEAN OIL | INACTIVE INGREDIENT | A2M91M918C | 2 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 2 | |
| MANGIFERA INDICA SEED BUTTER | INACTIVE INGREDIENT | 4OXD9M35X2 | 2 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 2 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 2 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61477-214 | 61477-214-14 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TOCOPHEROL | R0ZB2556P8 | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| SUNFLOWER OIL | 3W1JG795YI | IACT |
| HYDROGENATED SOYBEAN OIL | A2M91M918C | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| MANGIFERA INDICA SEED BUTTER | 4OXD9M35X2 | IACT |
| AVOCADO OIL | 6VNO72PFC1 | IACT |
| CASTOR OIL | D5340Y2I9G | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | 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 |
|---|---|---|---|---|---|---|
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | AEROSOL, FOAM / TOPICAL | 4 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, EXTENDED RELEASE / ORAL | 23.27 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / SUBLINGUAL | 1.6 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CAPSULE / ORAL | 4771 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | GEL / NASAL | 429 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SPRAY / TOPICAL | 540 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | INJECTION, EMULSION / INTRAVENOUS | 0.02 %w/v | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER / SUBLINGUAL | 2 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION / INTRAMUSCULAR | 885 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL, METERED / TOPICAL | 4 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | GRANULE, FOR SUSPENSION / ORAL | 128 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | EMULSION / OPHTHALMIC | 32 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | SOLUTION / TOPICAL | 1.38 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | CAPSULE / ORAL | 1.04 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET, COATED / ORAL | 3 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION, SOLUTION / INTRAMUSCULAR | 525 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | EMULSION / TOPICAL | 0.25 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET / ORAL | 3 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / TOPICAL | 10 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, EMULSION / INTRAVENOUS | 1.1 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET / ORAL | 13.5 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | SOAP / TOPICAL | 4.6 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, COATED / ORAL | 0.9 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / VAGINAL | 2 %w/w | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | TABLET / ORAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | CAPSULE / ORAL | 95 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / ORAL | 17 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / TOPICAL | 3 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | GEL / TOPICAL | 12 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE / ORAL | 3 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CREAM / TOPICAL | 3300 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOAP / TOPICAL | 0.02 %w/w | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | SOLUTION / TOPICAL | 15.5 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SUSPENSION / ORAL | 10170 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER, FOR SUSPENSION / ORAL | 3390 mg/5ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 0.02 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | OINTMENT / TOPICAL | 14.75 %w/w |
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 |
|---|---|---|---|---|---|---|
| 1149f7e7-6883-6ed7-e063-6394a90af721 | 3bb01ac0-ccba-46b3-8850-b04d0c651300 | 2024-02-13 | Warnings | 1149f7e7-6883-6ed7-e063-6394a90af721 3bb01ac0-ccba-46b3-8850-b04d0c651300 |
Adverse event summaries are temporarily unavailable. Other product information remains available.