Attitude
FDA Label NDC 61649-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bio Spectra for the product Attitude (NDC 61649-013). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, 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

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Or Non-medicinal Ingredients

→ Other Information

→ Principal Display Panel - 18.4 G Tube Carton

Other

DRUG FACTS

Active Ingredient

Zinc oxide (20%)

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. If rash occurs, discontinue use.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

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
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- Ask a doctor for use on children under 6 months of age.
- 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 10am–2pm
    - Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Or Non-Medicinal Ingredients

Olea europaea (olive) fruit oil, euphorbia cerifera (candelilla) wax, theobroma cacao (cocoa) seed butter, butyrospermum parkii (shea) butter, ricinus communis (castor) seed oil, cocos nucifera (coconut) oil, glyceryl stearate se, polyhydroxystearic acid.