Otc - Active Ingredient
ACTIVE INGREDIENTS
ZINC OXIDE 25%
TITANIUM DIOXIDE 5.5%
PURPOSE
SUNSCREEN
Tan Zinc Stick Spf 50 Stick
FDA Label NDC 84425-112
9 label sections · Submitted to the FDA by Standard Procedure Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Standard Procedure Inc for the product Tan Zinc Stick Spf 50 (NDC 84425-112). 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, indications & usage, warnings, dosage & administration, inactive ingredient, storage and handling, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
USES
• Helps prevent sunburn
• If used as directed with other sun protection measures (see Dit8cfions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
WARNINGS
• For external use only • Do not use on damaged or broken skin • Stop use and ask a doctor If rash occurs
• When using this product keep out of eyes • Rinse with water to remove • Keep out of reach of children
• If swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
DIRECTIONS
Apply generously and evenly 15 minutes before sun exposure• reapply 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 broad spectrum SPF of 15 or higher and other sun protection measures including: • Wmit lime in 111a si.-,, especially from 10 a.m. -2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses
• Use a water resistant sunscreen If swimming or sweating
• Children under 6 months: Ask a doctor
Inactive Ingredient
Ricinus Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Helianthus Annuus (Sunflower) Seed Wax, Kaolin, Euphorbia Cerifera {Candelilla) Wax, C12-15 Alkyl Benzoate, Triacontanyl PI/P, Cocos Nuclfera (Coconut) 011, SIiica Dimethyl Sllylate, Ethylhexyl Methoxycrylene, Polyhydroxystearlc Acid, Silica, Tocopheryl Acetate, Iron Oxides (CI 77491, 77492, 77499).
Storage And Handling
OTHER INFORMATION
PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN
Otc - Keep Out Of Reach Of Children
WARNINGS
• For external use only • Do not use on damaged or broken skin • Stop use and ask a doctor If rash occurs
• When using this product keep out of eyes • Rinse with water to remove • Keep out of reach of children
• If swallowed, get medical help or contact a Poison Control Center right away
Otc - Purpose
PURPOSE
SUNSCREEN
Package Label.Principal Display Panel
STANDARD PROCEDURE
TAN ZINC STICK
SPF 50
AUSTRALIAN MADE
BROAD SPECTRUM SUNSCREEN
UVA/UVB PROTECTION
VISIBLE TAN TINTED BARRIER CREAM
NATURALLY DERIVED ZINC
PROVIDES PROTECTION THROUGH WEATHER, WAVES AND PERSPIRATION
HIGH PERFORMANCE PROTECTION FOR HIGH EXPOSURE DAYS
17G / 0.6 OZ
Tan Zinc Stick USA 250721
* Please review the disclaimer below.
