Label: ESSENTIALS FACE AND BODY SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 14222-0002-1
- Packager: Rodan & Fields
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 2, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (w/w)
- Purpose
-
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
-
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
-
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
-
INGREDIENTS AND APPEARANCE
ESSENTIALS FACE AND BODY SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct 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 04/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/10/2020 Labeler - Rodan & Fields (051659584)
