Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3%.....Sunscreen
Octinoxate 4%
Octocrylene 2.7%
Oxybenzone 3%
Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum Spf30 Cream
FDA Label NDC 70157-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Baxter Laboratories Pty. Ltd. for the product Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum Spf30 (NDC 70157-035). 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
- 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
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
For external use only
Do not use on damaged or broken skin.
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating.
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 value 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-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- Use a water resistant sunscreen if swimming or sweating
Inactive Ingredient
Inactive Ingredients
Lanolin, Theobroma cacao (cocoa) seed butter, ricinus communis (castor) seed oil, cera alba (beeswax), butyrospermum parkii (shea) butter, aroma (flavor), vitis vinifera (grape) seed oil, mica, tocopherol (vit E), glycine soja (soybean) oil, cocos nucifera (coconut) oil, vegetable oil, prunus amygdalus dulcis (sweet almond) oil, CI 77891 (titanium dioxide), CI 77491 (iron oxides)
Package Label.Principal Display Panel
Lanolips
SPF 30
Sun Balm Tropical
untinted Lip Balm
12.5G/ .44 OZ Net Wt. Poids Net
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