Otc - Active Ingredient
Zinc Oxide – 36%
Tanri Broad Spectrum Spf 30 Lotion
FDA Label NDC 65112-305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by I. Shay Cosmetics for the product Tanri Broad Spectrum Spf 30 (NDC 65112-305). 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, inactive ingredient, warnings, dosage & administration, 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
Sunscreen
Otc - Keep Out Of Reach Of Children
WARNING: Keep out of reach of children
Indications & Usage
Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer, early aging by the sun.
Inactive Ingredient
Purified Water
C12-C15 Alkyl Benzoate
Isostearic Acid
Polyhydroxystearic Acid
Butyloctyl Salicylate
Caprylic Capric Triglycerides
Cetyl/ PEG/ PPG-10/ 1 Dimethicone
Glycerin
Hydroxyethyl Cellulose
Isododecane
Jojoba Esters
Phenoxyethanol
Benzoic Acid
Ethylhexylglycerin
Glycereth-2 Cocoate
Polyglyceryl-2 Dipolyhydroxystearate
Sodium Chloride
Sodium Hyaluronate Acid
Squalane
Triethoxycaprylylsilane
Eicosene Copolymer
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.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Shake well before use.
Apply liberally 15 minutes before sun exposure.
Reapply: after 80 minutes of swimming or sweating; at least every 2 hours; Immediately after towel drying.
Retains SPF after 80 minutes of activity in the water, sweating & perspiring.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, Regularly use a sunscreen with broad spectrum SPF of 5 or higher and other sun protection measures including:
- limit time in the sun, especially from 10a.m. - 2p.m.
- wear long-sleeves shirts, pants, hats, & sunglasses
Children under 6 months, ask a doctor.
* Please review the disclaimer below.
