Tinted Lip Balm SPF30 Sienna Rose

Manufacturer
Autumn Harp
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:16:41

Label at a glance#

ProductTinted Lip Balm SPF30 Sienna Rose
Active ingredientZINC OXIDE
Label structure9 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 suncscreen 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

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 the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not useon damaged or broken skin.

When using this product keep out of eyes. Rinse with water ro remove.

Stop use and ask a doctor if rash occurs.

Directions

INSTRUCTIONS FOR USE SECTION

  • For suncscreen 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.
  • 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

Sesamum Indicum (Sesame) Seed Oil, Oleic/Linoleic/Linolenic Polyglycerides, Isoamyl Laurate, 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, Carmine, Iron Oxides.

* Natural Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary label_1Primary label_1image components

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51514-0358-12023-12-28C16284748780-1f386c649-d061-0266-e053-dadaa90a7c1aTinted Lip Balm SPF30 Sienna Rose
51514-0358-12023-01-30C16284748780-1f386c649-d061-0266-e053-dadaa90a7c1aTinted Lip Balm SPF30 Sienna Rose

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51514-035851514-0358-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

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
f1efc0bf-e09c-4b70-e053-2995a90a53ddd06111b2-f9bb-7404-e053-2995a90a607d2023-01-10WarningsExact identifier
spl id: f1efc0bf-e09c-4b70-e053-2995a90a53dd
spl set id: d06111b2-f9bb-7404-e053-2995a90a607d

Reported adverse events (FAERS/openFDA)#

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