Essentials Face And Body Sunscreen Lotion
FDA Label NDC 14222-0002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rodan & Fields for the product Essentials Face And Body Sunscreen (NDC 14222-0002). 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 ingredients (w/w), purpose, uses, warnings, do not use on, otc - when using, 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

Active Ingredients (W/W)

Avobenzone 2.8%, Homosalate 9.6%, Octisalate 4.8%, Octocrylene 9.6%

Purpose

Sunscreen

Uses

Helps prevent sunburn. When 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

Otc - When Using

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

Otc - Stop Use

Stop use and ask doctor if 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 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying
  • 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 10 a.m.-2 p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, Glycerin, Butylene Glycol, Pentylene Glycol, C12-15 Alkyl Benzoate, Silica, Dimethicone, Hydrogenated Lecithin, Fragrance/Parfum, Dimethicone/Vinyl Dimethicone Crosspolymer, Xanthan Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Carbomer, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Diethylhexyl Syringylidenemalonate, Aminomethyl Propanol, Citric Acid Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Citral, Limonene, Linalool, Titanium Dioxide (CI 77891).

Principal Display Panel – 150 Ml Carton Label

RODAN+FIELDS

ESSENTIALS

Face + Body
Sunscreen

Broad
Spectrum

SPF
50

Everyday
Active

Broad Spectrum SPF 50
Water Resistant (80 Minutes)

RODAN + FIELDS

150 mL/5.0 Fl. Oz. U.S.

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