Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3.5% Sunscreen
Homosalate 5.0% Sunscreen
Octocrylene 5.0% Sunscreen
Octisalate 5.0% Sunscreen
Hydrating Lip Balm Spf 15 Sunscreen
FDA Label NDC 76261-127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Australian Skin Products Pty Ltd for the product Hydrating Lip Balm Spf 15 Sunscreen (NDC 76261-127). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses: Helps prevent sunburn and chapped lips. 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
Warnings:
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
Dosage & Administration
Directions
Apply Liberally to lips as often as desired
Apply liberally 15 minutes before sun exposure
Reapply: at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Sun Protectection 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 15 or higher and other skin protection measures including:
- Limit time in the sun especially from 10 a.m. -2 p.m.
- Wear long-sleeve shirts, pants, and sunglasses
- Children under 6 months ask a doctor
Inactive Ingredient
Hydrogenated Polysiobutene, Ethylene/Propylene/Styrene Copolymer, Nicinamide, Rohododendron Ferruineum (Alpine Rose) Extract, Tricaprylin, Polyamide-3, Ethyl Macadamiate, Bisabolol, Tocopherol, Zingiber Officinale (Ginger) Root Extract, Glycerin, Malic Acid, Citrus Reticulata (Tangerine) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Medica Limonium (Lemon) peel Oil, Ethyl Methylphenylglycidate, Butylene/Ethylene/Styrene Copolymer, BHT,limonene.
Package Label.Principal Display Panel
asap
the science of beautiful
hydrating lip balm+
with niacinamide +Alpine Rose
protect
SPF 15 SUNSCREEN
10mL/0.34floz
* Please review the disclaimer below.
