Label: DAILY DOSE VITAMIN C AND BROAD SPECTRUM SPF 40 SERUM- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 75936-136-01, 75936-136-02, 75936-136-03
- Packager: Supergoop LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 4, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply generously and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating
- 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 your time in the sun, especially from 10
a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses •
- Children under 6 months of age: ask a doctor.
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INACTIVE INGREDIENT
Inactive Ingredients Water (Aqua), 3-0-Ethyl Ascorbic Acid, C13-15 Alkane, Glycerin, Polyglyceryl-6 Ricinoleate, Polyglyceryl-6 Polyhydroxystearate, Octyldodecyl Citrate Crosspolymer, Niacinamide, Phenethyl Benzoate, Polyester-25, Silica, Terminalia Ferdinandiana Fruit Extract, Rosa Centifolia Flower Extract, Jasminum Officinale (Jasmine) Flower Extract, Bellis Perennis (Daisy) Flower Extract, Hydrolyzed sodium Hyaluronate, Sodium Hyaluronate, Pseudoalteromonas Ferment Extract, Glyceryl Caprylate, Disteardimonium Hectorite, Xanthan Gum, Polyglyceryl-2 Isostearate, Magnesium Sulfate, Sodium Chloride, Citric Acid, Trisodium Ethylenediamine Dissucinate, Sodium Citrate, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Chlorphenesin.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAILY DOSE VITAMIN C AND BROAD SPECTRUM SPF 40 SERUM
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-136 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) KAKADU PLUM (UNII: 0ZQ1D2FDLI) NIACINAMIDE (UNII: 25X51I8RD4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PENTYLENE GLYCOL (UNII: 50C1307PZG) PROPANEDIOL (UNII: 5965N8W85T) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) WATER (UNII: 059QF0KO0R) C13-15 ALKANE (UNII: 114P5I43UJ) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) SODIUM CITRATE (UNII: 1Q73Q2JULR) PHENETHYL BENZOATE (UNII: 0C143929GK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC) ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O) BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) 3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-136-01 30 mL in 1 CARTON; Type 0: Not a Combination Product 09/08/2020 2 NDC:75936-136-02 5 mL in 1 CARTON; Type 0: Not a Combination Product 09/08/2020 11/01/2020 3 NDC:75936-136-03 1.5 mL in 1 CARTON; Type 0: Not a Combination Product 09/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/08/2020 Labeler - Supergoop LLC (117061743)