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  5. Label Information: Essentials Face And Body Sunscreen

FDA Label for Essentials Face And Body Sunscreen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (W/W)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE ON
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL – 150 ML CARTON LABEL

Essentials Face And Body Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Rodan & Fields. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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