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Drug Facts
Tiege Hanley Moisturizing Lip Balm Spf 30
FDA Label NDC 65692-1004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose, Inc. for the product Tiege Hanley Moisturizing Lip Balm Spf 30 (NDC 65692-1004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients
Zinc Oxide 7.5%
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Uses • Helps prevent sunburn and chapped lips
Warnings
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
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
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
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
Box Label
res
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