Active Ingredients
Zinc Oxide 25%
Maniscreen Hydrating Mineral Hand Sunscreen Spf 25 Rosewater Lotion
FDA Label NDC 87618-105
12 label sections · Submitted to the FDA by Underlining, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Underlining, Inc. for the product Maniscreen Hydrating Mineral Hand Sunscreen Spf 25 Rosewater (NDC 87618-105). 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 active ingredients, purpose, uses, 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
Purpose
Sunscreen
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
- 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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- 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 of age: Ask a doctor.
Other Information
- Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Aqua (Water), Potassium Cetyl Phosphate, Glycerin, Butylene Glycol, Cetearyl Alcohol, Niacinamide, Sorbitan Stearate, Polysorbate 60, Oryza Sativa (Rice) Bran Oil, Propanediol, 1,2-Hexanediol, Hyaluronic Acid, Tocopherol (Vitamin E), Dimethicone, Ethylhexylglycerin, Pentylene Glycol, Centella Asiatica (Gotu Kola) Extract, Polygonum Cuspidatum (Japanese Knotweed) Root Extract, Limonia Acidissima (Wood Apple) Extract, Silica, Phenoxyethanol, Caprylyl Glycol, Panthenol, Scutellaria Baicalensis (Chinese Skullcap) Root Extract, Camellia Sinensis (Green Tea) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Beta-Glucan, Lavandula Angustifolia (Lavender) Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Disodium EDTA, Sodium Hyaluronate, Fragrance, Tetramethyl Acetyloctahydronaphthalenes, Hexamethylindanopyran.
Package Label.Principal Display Panel
Maniscreen_rosewater_carton (Maniscreen Rosewater Carton)
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