Otc - Active Ingredient
Active Ingredients
Zinc Oxide 21%
Lather- Daily Defense Mineral Spf 50 Body Sunscreen Cream
FDA Label NDC 77394-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lather, Inc. for the product Lather- Daily Defense Mineral Spf 50 Body Sunscreen (NDC 77394-203). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose Sunscreen
Indications & Usage
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
Warnings
Warnings For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
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.
Other
Other information: protect this product from excessive heat and direct
Dosage & Administration
Directions: Apply liberally 15 minutes before sun exposure. reapply: after 80 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 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-sleeve shirts, pants, hats, and sunglasses, children under 6 months of age: ask a doctor
Inactive Ingredient
Inactive ingredients: Water (Aqua), Coco Caprylate/Caprate, Cetearyl Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, Sorbitan Olivate, Caprylhydroxamic Acid, Glyceryl Caprylate, Glycerin, Xanthan Gum, Equisetum Arvense (Horsetail) Extract, Rosmarinus Officinalis (Rosemary) Extract, Centella Asiatica (Gotu Kola) Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Camellia Sinensis (Green Tea) Extract, Olea Europaea (Olive) Leaf Extract, Tocopheryl Acetate, Potassium Sorbate, Sodium Phytate, Silica, Triethoxycaprylylsilane, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Ascorbic Acid, Tocopherol, Citric Acid
Lather - Daily Defense Mineral Spf 50 - 3 Fl Oz / 88 Ml
daily defense mineral SPF 50
body sunscreen with UVA/UVB protection
Lather
Lather (daily defense mineral SPF 50)
broad spectrum SPF 50
water resistant (80 minutes)
FRAGRANCE-FREE
for adults and children
3 fl oz / 88 mL
* Please review the disclaimer below.
