FDA.reportPublic FDA data

Tiege Hanley Moisturizing Lip Balm SPF 30

Manufacturer
Raining Rose, Inc.
Effective date
2020-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:14

Label at a glance#

ProductTiege Hanley Moisturizing Lip Balm SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Zinc Oxide 7.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Uses • Helps prevent sunburn and chapped lips

WARNINGS SECTION

Warnings
For External Use Only • Do not use on damaged
or broken skin • Stop use and ask a doctor if rash
occurs • When using this product keep out of eyes.
• Rinse with water to remove • If swallowed get medical
help or contact Poison Control Center right away.
• Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions •Apply generously 15 minutes before sun exposure
• Reapply at least every two hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months ask a doctor

OTHER SAFETY INFORMATION

Other Information: Protect this product from excessive
heat and sun. This product is sealed with a tamper
evident label. Do not use if label is missing or broken.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Pentaerythrityl Tetraisostearate, Oryza Sativa (Rice) Bran Wax, Prunus Amygdalus Dulcis
(Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Glyceryl Stearate, Squalene, Behenyl
Alcohol, Moringa Oleifera Seed Oil, Caprylic/Capric Triglyceride, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia
Chinensis (Jojoba) Seed Oil, Citrus Reticulata Blanco (Tangerine) Oil, Polyhydroxystearic Acid, Undaria Pinnatifida
Extract, Mentha Piperita (Peppermint) Oil

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TIEGE

HANLEY

Uncomplicated

Skin Care for Men​®

​

LIP

Moisturizing Lip Balm

with SPF 30

Net Wt 0.15 oz (4.2 g)

Made in the USA

MFD for Tiege Hanley LLC

Chuicago, IL 60612

Tiege.com

Tube Label

331758 Tube331758 Tube

Box Label

Tieg-Henly BoxTieg-Henly Box

res

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65692-1004-12024-01-30C16284748780-11030e365-3a3e-111a-e063-dadaa90a10e2Tiege Hanley Moisturizing Lip Balm SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-1004-1Tiege Hanley Moisturizing Lip Balm SPF 304.2 g in 1 TUBESTICK4.21
65692-1004-1Tiege Hanley Moisturizing Lip Balm SPF 301 in 1 PACKAGESTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-1004TIEGE HANLEY MOISTURIZING LIP BALM SPF 30 (ZINC OXIDE) STICK [RAINING ROSE, INC.]1Legacy NDC, 2 package rows20200414_c5574cfd-5b96-4036-8704-2c058dca5db3.zip

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
65692-100465692-1004-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
RICE BRANR60QEP13ICIACT
ALMOND OIL66YXD4DKO9IACT
SUNFLOWER OIL3W1JG795YIIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SQUALENE7QWM220FJHIACT
DOCOSANOL9G1OE216XYIACT
MORINGA OLEIFERA SEED OILREM6A5QMC0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
JOJOBA OIL724GKU717MIACT
MANDARIN OILNJO720F72RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
UNDARIA PINNATIFIDAICV1OK7M1SIACT
PEPPERMINT OILAV092KU4JHIACT

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
4198ba52-509a-4ac1-a891-fd4f6887b5edc5574cfd-5b96-4036-8704-2c058dca5db32020-04-13WarningsExact identifier
spl id: 4198ba52-509a-4ac1-a891-fd4f6887b5ed
spl set id: c5574cfd-5b96-4036-8704-2c058dca5db3

Reported adverse events (FAERS/openFDA)#

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