Spf 30 Sunscreen Stick
FDA Label NDC 63645-329

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oralabs for the product Spf 30 Sunscreen Stick (NDC 63645-329). 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 ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10%................Sunscreen

Purpose

Sunscreen

Keep Out Of Reach Of Children

If swallowed get medical help or contact a Poison Control Center immediately.

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: 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 or irritation develops and lasts.

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 the 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.

Inactive Ingredients

Paraffin wax, octyl palmitate, ozokerite, euphorbia cerifera (candelilla) wax, beeswax, butyloctyl salicylate, fragrance, polyethylene, polycrylene, cetyl alcohol, tocopheryl acetate, ascorbyl palmitate

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