YesTo Pomegranate Lip Butter with SPF 15

Manufacturer
Autumn Harp, Inc.
Effective date
2013-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:39:43

Label at a glance#

ProductYesTo Pomegranate Lip Butter with SPF 15
Active ingredientZinc Oxide
Label structure8 sections

Indications and uses

Helps prevent sunburn • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by sun.

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: ask a doctor. Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the ...

Label contents#

Full prescribing information#

Active Ingredient

WARNINGS AND PRECAUTIONS SECTION

Zinc Oxide (7.6%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by sun.

Warnings

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 Doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

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.

Sun Protection Measure

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeved shirts, pants, hats and sun-glasses. 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Flavor, Glycine Soja (Soybean) Oil, Copernicia Cerifera (Carnauba) Wax, Jojoba Esters, Butyrospermum Parkii (Shea Butter)*, Ammonium Glycyrrhizate, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Extract*, Limonene, Linalool. * Certified Organic Ingredient

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image Components

image descriptionimage description

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image Components

image descriptionimage descriptionimage descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51514-0307-12019-11-27C16284748780-19855d018-d5c5-cd31-e053-dbdaa90ab51aYesTo Pomegranate Lip Butter with SPF 15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51514-0307YESTO POMEGRANATE LIP BUTTER WITH SPF 15 (ZINC OXIDE) STICK [AUTUMN HARP, INC.]1Legacy NDC20130925_592968a3-94bd-458c-b837-4b97981375a4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26C1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CITRALINACTIVE INGREDIENTT7EU0O9VPP1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L1
DECYL JOJOBATEINACTIVE INGREDIENTZL61O8TFZU1
EUGENOLINACTIVE INGREDIENT3T8H1794QW1
GERANIOLINACTIVE INGREDIENTL837108USY1
LIMONENE, (+/-)-INACTIVE INGREDIENT9MC3I344471
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
POMEGRANATEINACTIVE INGREDIENT56687D1Z4D1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SOYBEAN OILINACTIVE INGREDIENT241ATL177A1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51514-030751514-0307-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 50 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AAEROSOL, FOAM / TOPICAL50 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM, AUGMENTED / TOPICAL10 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT, AUGMENTED / TOPICAL429 mgExact identifier — unii candidate
15 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE / ORAL79 mgExact identifier — unii candidate
15 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS223 mgExact identifier — unii candidate
7 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FSUPPOSITORY / RECTAL265 mgExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, COATED / ORAL3 mgExact identifier — unii candidate
15 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii candidate
15 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, DELAYED RELEASE / ORAL230 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, EXTENDED RELEASE / ORAL2150 mgExact identifier — unii candidate
11 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, DELAYED RELEASE / ORAL0.08 mgExact identifier — unii candidate
15 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, EMULSION / INTRAVENOUS107100 mgExact identifier — unii candidate
7 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ACAPSULE / ORAL1318 mgExact identifier — unii candidate
7 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii candidate
11 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED, EXTENDED RELEASE / ORAL140 mgExact identifier — unii candidate
11 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE, EXTENDED RELEASE / ORAL288 mgExact identifier — unii candidate
11 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ASOLUTION / TOPICAL5.82 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / VAGINAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FLOTION / TOPICAL1 %w/wExact identifier — unii candidate
15 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8b61ef0a-ae74-4347-8cfd-52da928fb227592968a3-94bd-458c-b837-4b97981375a42013-09-19WarningsExact identifier
spl id: 8b61ef0a-ae74-4347-8cfd-52da928fb227
spl set id: 592968a3-94bd-458c-b837-4b97981375a4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.