Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm
- Manufacturer
- The Hain Celestial Group, Inc.
- Effective date
- 2012-05-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:31:45
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Ethylhexyl Dimethyl PABA 7.5%
Benzophenone-3 5.0%
OTC - PURPOSE SECTION
Sunscreen
INDICATIONS & USAGE SECTION
Helps prevent sunburn
WARNINGS SECTION
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 skin rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact Poison Center right away.
DOSAGE & ADMINISTRATION SECTION
Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 mos ask a doctor.
Skin Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging.
INACTIVE INGREDIENT SECTION
Ricinus Communis (Castor) Seed Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Lanolin, Copernicia Cerifera (Carnauba) Wax, Glycine Soja (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Olea Europaea (0live)Fruit Oil, Echinacea Purpurea Extract, Vanilla Planifolia Fruit Extract, Ammonium Glycyrrhizate, Tocopherol, Tocopheryl Acetate.
(1) Certified Organic Ingredient
OTC - QUESTIONS SECTION
Questions? Call 888-659-7730 or visit
www.AlbaBotanica.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61995-2921-1 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c43d-f6ea-e053-dbdaa90aa703 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61995-2921-1 | Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm | 1 in 1 CARTON | STICK | 1 | 1 | |
| 61995-2921-1 | Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm | 4.2 g in 1 CONTAINER | STICK | 4.2 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61995-2921 | ALBA BOTANICA UN-PETROLEUM VANILLA SPF18 LIP BALM (ETHYLHEXYL DIMETHYL PABA, BENZOPHENONE-3) STICK [THE HAIN CELESTIAL GROUP, INC.] | 1 | Legacy NDC, 2 package rows | 20120511_88b44518-5dc8-4791-92f3-eed4b70061e1.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| PADIMATE O | ACTIVE INGREDIENT | Z11006CMUZ | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| PADIMATE O | ACTIVE MOIETY | Z11006CMUZ | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| AMMONIUM GLYCYRRHIZATE | INACTIVE INGREDIENT | 3VRD35U26C | 1 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | 1 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | 1 | |
| ECHINACEA PURPUREA | INACTIVE INGREDIENT | QI7G114Y98 | 1 | |
| EVENING PRIMROSE OIL | INACTIVE INGREDIENT | 3Q9L08K71N | 1 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| OLIVE OIL | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| VANILLA | INACTIVE INGREDIENT | Q74T35078H | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm
- Ethylhexyl Dimethyl PABA, Benzophenone-3
- PADIMATE O
- OXYBENZONE
- CASTOR OIL
- YELLOW WAX
- CANDELILLA WAX
- JOJOBA OIL
- LANOLIN
- CARNAUBA WAX
- SOYBEAN OIL
- EVENING PRIMROSE OIL
- OLIVE OIL
- ECHINACEA PURPUREA
- AMMONIUM GLYCYRRHIZATE
- TOCOPHEROL
- .ALPHA.-TOCOPHEROL ACETATE
- COCONUT OIL
- VANILLA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61995-2921 | 61995-2921-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PADIMATE O | Z11006CMUZ | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| CASTOR OIL | D5340Y2I9G | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| CANDELILLA WAX | WL0328HX19 | IACT |
| JOJOBA OIL | 724GKU717M | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| EVENING PRIMROSE OIL | 3Q9L08K71N | IACT |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| ECHINACEA PURPUREA | QI7G114Y98 | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| VANILLA | Q74T35078H | IACT |
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, FILM COATED / ORAL | 0.8 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | OINTMENT / TOPICAL | 14.75 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | EMULSION / OPHTHALMIC | 32 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / TOPICAL | 10 %w/w | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOAP / TOPICAL | NA | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / TOPICAL | 0.6 %w/w | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET / ORAL | 4 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, DELAYED RELEASE / ORAL | 1 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / RECTAL | 105 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | GRANULE, FOR SUSPENSION / ORAL | 128 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / VAGINAL | 2 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | AEROSOL, FOAM / TOPICAL | 50 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SHAMPOO / TOPICAL | 2 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | SPRAY / NASAL | NA | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | SOAP / TOPICAL | 4.6 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | EMULSION / TOPICAL | 0.25 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / SUBLINGUAL | 1.6 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | TABLET / ORAL | NA | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / ORAL | 425 mg/1ml | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | CAPSULE / ORAL | 1318 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | CAPSULE / ORAL | 1.04 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | GEL / NASAL | 429 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, EXTENDED RELEASE / ORAL | 3 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | LOTION / TOPICAL | 32468 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION, SOLUTION / INTRAMUSCULAR | 525 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | SOLUTION / TOPICAL | 5.82 %w/w | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | INJECTION, EMULSION / INTRAVENOUS | 0.02 %w/v | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / ORAL | 17 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / OPHTHALMIC | 3 %w/w | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | INJECTION / INTRAVENOUS | 10 %w/v | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SPRAY / NASAL | NA | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, FILM COATED / ORAL | 15.29 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | CAPSULE / ORAL | NA | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 223 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, EXTENDED RELEASE / ORAL | 23.27 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | OINTMENT / TOPICAL | 14.9 %w/w | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | AEROSOL, FOAM / TOPICAL | 23.6 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 10 %w/v |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 30695b6c-a104-441c-bc7b-39b6e86fcfc2 | 88b44518-5dc8-4791-92f3-eed4b70061e1 | 2012-05-10 | Warnings | 30695b6c-a104-441c-bc7b-39b6e86fcfc2 88b44518-5dc8-4791-92f3-eed4b70061e1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

