Broad Spectrum Spf 30 Sunscreen Lotion
FDA Label NDC 65692-0567

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose for the product Broad Spectrum Spf 30 Sunscreen (NDC 65692-0567). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Safety Information

→ Inactive Ingredient

→ Package Label.principal Display Panel

Otc - Active Ingredient

Zinc Oxide (18.75%)

Otc - Purpose

Sunscreen

Indications & Usage

Helps prevent Sunburn

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.

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.

Dosage & Administration

Directions

Apply liberally 15 minutes before sun exposure
Reapply after 80 minutes of swimming or sweating.
Reapply immediately after towel drying.
Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor

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 sunprotection measures including: