FDA.reportPublic FDA data

Tinted Lip Balm SPF30 Wild Peony

Manufacturer
Autumn Harp
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:55

Label at a glance#

ProductTinted Lip Balm SPF30 Wild Peony
Active ingredientZINC OXIDE
Label structure11 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 the sun.

Dosage and administration

For sunscreen use Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun,...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 19.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION 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 the 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 a doctor if rash occurs.

Directions

INSTRUCTIONS FOR USE SECTION

  • For sunscreen use
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • children under 6 months: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Isoamyl Laurate, Sesamum Indicum (Sesame) Seed Oil, Oleic/Linoleic/Linolenic Polyglycerides, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Fruit Oil, Ricinus Communis (Castor) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Beeswax, Flavor*, Glyceryl Behenate, Glyceryl Stearate, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Dioctyldecyl Dimer Dilinoleate, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum Seed Butter, Glyceryl Caprylate, Propanediol, Tocopherol, Bisabolol, Glyceryl Undecylenate, Glycine Soja (Soybean) Oil, Ammonium Glycyrrhizate, Mica, Carmine, Titanium dioxide, Iron Oxides.

* Natural Flavor

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Apply as needed

For external use only

Do not use on damaged or broken skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image components Primary label_1Primary label_1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51514-0357-12023-12-28C16284748780-1f386c64a-072b-0266-e053-dadaa90a7c1aTinted Lip Balm SPF30 Wild Peony
51514-0357-12023-01-30C16284748780-1f386c64a-072b-0266-e053-dadaa90a7c1aTinted Lip Balm SPF30 Wild Peony

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51514-0357-1Tinted Lip Balm SPF30 Wild Peony1 g in 1 CYLINDERSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51514-0357TINTED LIP BALM SPF30 WILD PEONY (SPF30 LIP BALM) STICK [AUTUMN HARP]2Current NDC, Legacy NDC, 1 package rows20231229_d0604720-623a-e8a9-e053-2995a90ab0e6.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51514-035751514-0357-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
YELLOW WAX2ZA36H0S2VIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMERTY3J98ZR7RIACT
SHEA BUTTERK49155WL9YIACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
CASTOR OILD5340Y2I9GIACT
SUNFLOWER OIL3W1JG795YIIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
ARGAN OIL4V59G5UW9XIACT
ALMOND OIL66YXD4DKO9IACT
ISOAMYL LAURATEM1SLX00M3MIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
GLYCERINPDC6A3C0OXIACT
SOYBEAN OIL241ATL177AIACT
SESAME OILQX10HYY4QVIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
VANILLA BEANQ74T35078HIACT
OLIVE OIL6UYK2W1W1EIACT
COCONUT3RT3536DHYIACT
JOJOBA OIL724GKU717MIACT
WHEAT GERM OIL14C97E680PIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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
Tinted Lip Balm SPF30 Wild PeonySPF30 LIP BALMAutumn Harpd0604720-623a-e8a9-e053-2995a90ab0e62023-01-10WarningsExact identifier
ndc (package): 51514-0357-1
ndc (product): 51514-0357
ndc11 (package): 51514035701
spl id: f1efbede-120a-4d12-e053-2995a90a0d82
spl set id: d0604720-623a-e8a9-e053-2995a90ab0e6

Reported adverse events (FAERS/openFDA)#

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