Otc - Active Ingredient
ACTIVE INGREDIENTSNon-Nano Zinc Oxide 12%
PURPOSESunscreen
Titan Tallow Spf 50 Organic Tallow Sunscreen Cream
FDA Label NDC 87761-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Moes Group Llc for the product Titan Tallow Spf 50 Organic Tallow Sunscreen (NDC 87761-007). 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, warnings, dosage & administration, indications & usage, 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
Helps prevent sunburnIf used as directed with other sun protectionmeasures (see Directions), decreases the risk ofskin 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.
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.
Stop use and ask a doctor if rash occurs.
Dosage & Administration
Shake well prior to use
Apply liberally 15 minutes before sun exposure
Children under 6 months of age: ask a doctor
. After 80 minutes of swimming or sweating
· Immediately after towel drying
At least every 2 hours
Indications & Usage
Sun Protection Measures. Spending time in the sunincreases your risk of skin cancer and early skin aging.To decrease this risk, regularly use a sunscreen with aBroad Spectrum SPF value of 15 or higher and other sunprotection measures including:
· Limit time in the sun, especially from 10 a.m.-2 p.m.· Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
INACTIVE INGREDIENTS100% grass-fed beef tallow, organic jojoba oil, organicbeeswax, vanilla planifolia (vanilla) oil, tocopherol (vitamin E).
Package Label.Principal Display Panel
Labeling (87761 007 01)
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