Otc - Active Ingredient
Active Ingredient Purpose
Titanium Dioxide 3.32% Sunscreen
Spf 30 Lip Balm Stick
FDA Label NDC 53634-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Malin And Goetz Inc for the product Spf 30 Lip Balm (NDC 53634-129). 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, 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 - 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
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
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 and evenly 15 minutes before sun exposure
- Children under 6 months of age: Ask a doctor
- Limit time in the sun especially from 10 am- 2pm
- Wear long-sleeved shirts, pants, hats & sunglasses
- Reapply after 40 minutes of swimming or sweating
- Immediately after towel drying
- 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 value of 15 or higher and other sun protection measures including:
Other Safety Information
Other information
- Protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive Ingredients
Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Hydrogenated Styrene/Isoprene Copolymer, Hydrogenated Polydecene, Flavor, Cinnamal, Cinnamyl Alcohol, Coumarin, d-Limonene, Eugenol, Methyl 2 Octynoate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Urolic Acid, Tocopherol, Stearic Acid, Aluminum Hydroxide.
Package Label.Principal Display Panel
(Malin+Goetz)
spf 30 lip balm.
Broad Spectrum Mineral Sunscreen
Water Resistant 40 minutes
0.3fl. oz./10ml
* Please review the disclaimer below.
