Raf Five - Kick Off Hydrating Broad Spectrum Spf30 Sunscreen
FDA Label NDC 66163-4453

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Solutions Llc for the product Raf Five - Kick Off Hydrating Broad Spectrum Spf30 Sunscreen (NDC 66163-4453). 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 ingredients, purpose, uses, warnings, when using this product, otc - stop use, 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

Drug Facts

Distributed by ILERA DERM LLC,
a subsidiary of Zelira Therapeutics LTD.
5110 Campus Drive Plymouth Meeting, PA 19462

Active Ingredients

Titanium Dioxide 6.0%
Zinc Oxide 7.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only

When Using This Product

  • Do not get into eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor.

  • If irritation or rash occurs.

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 and spread evenly 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 this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
        • Limit time in the sun, especially from 10 am - 2 pm.
        • Wear long-sleeve shirts, pants, hats and sunglasses.
        • Children under 6 months of age: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun. Store at room temperature (59-85°).

Inactive Ingredients

Water (Aqua), Caprylic/ Capric Triglyceride, Undecane, Pentylene Glycol, Steareth-2 Glycerin, Cetearyl Alcohol, Niacinamide, PPG-12/SMDI Copolymer, Silica, Steareth -21 Tridecane, Polyhydroxystearic Acid, Propanediol, Cannabidiol, Ergothioneine, Dipotassium Glycyrrhizate, Zingiber Officinale (Ginger) Root Extract, Artemisia Vulgaris Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Juniperus Virginiana Oil, Mentha Citrata Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Vitis Vinifera (Grape) Seed Oil, Sodium Hyaluronate, Bisabolol, Alumina, Stearic Acid.

Principal Display Panel - 50 Ml Bottle Carton

RAF™
FIVE

KICK OFF
HYDRATING LOTION

BROAD SPECTRUM
SPF30
SUNSCREEN

with CBD

1.7 fl. oz. / 50 mL

Principal Display Panel (50 mL Bottle Carton)

Principal Display Panel (50 mL Bottle Carton)

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