Otc - Active Ingredient
Active Ingredient Purpose
Titanium Dioxide 3.71% Sunscreen
Zinc Oxide 2.71% Sunscreen
Spf 30 Mineral Sunscreen Cream
FDA Label NDC 53634-128
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 Mineral Sunscreen (NDC 53634-128). 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
Keep out of reach of children
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
- wear long-sleeved shirts, pants, hats, and 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:
limit your time in the sun, especially from 10a.m. – 2 p.m.
Inactive Ingredient
Inactive ingredients
Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Niacinamide, Coconut Alkanes, Alumina, Glycogen, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hyaluronate, Diethylhexyl Syringlidenemalonate, Triethoxycaprylylsilane, Ursolic Acid, Stearic Acid, Polyhydroxystearic Acid, hydrogenated Lecithin, Benzyl Alcohol, Phenoxyethanol, Tocopheryl Acetate, Coco-Caprylate/Caprate, Aminomethyl Propanol, Xanthan Gum, Citric Acid.
Package Label.Principal Display Panel
(Malin+Goetz)
spf 30 mineral sunscreen
Broad Spectrum
Water-Resistant 40 minutes
1.7 fl.oz./50 ml
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