ESSENTIALS FACE AND BODY SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

ESSENTIALS Face and Body Sunscreen by

Drug Labeling and Warnings

ESSENTIALS Face and Body Sunscreen by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Stop use and ask doctor if rash occurs

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.

INGREDIENTS AND APPEARANCE

ESSENTIALS FACE AND BODY SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.028 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.096 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.048 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.096 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-0002-1	150 mL in 1 TUBE; Type 0: Not a Combination Product	04/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/02/2020

Labeler - Rodan & Fields (051659584)