Label: NUTRICENTIALS DAY DREAM PROTECTIVE- homosalate, octisalate, avobenzone, and octocrylene lotion
- NDC Code(s): 62839-1555-1
- Packager: NSE Products, Inc.
- 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 January 13, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- Helps prevent sunburn. Higher SPF gives more sunburn protection.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warning
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Directions
- Using fingertips, apply generously to clean face and neck in an upward, outward motion. Use every morning before makeup application.
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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 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-sleeved shirts, pants, hats, and sunglasses
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: ask a doctor
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Inactive Ingredients
Water (Aqua), Butylene Glycol, C12-15 Alkyl Benzoate, Caprylyl Methicone, Isodecyl Neopentanoate, Pentylene Glycol, Polyglyceryl-6 Stearate, Butyloctyl Salicylate, Cetyl Dimethicone, Potassium Cetyl Phosphate, Triacontanyl PVP, Silica, Zingiber Officinale (Ginger) Root Extract, Carnosine, Cucurbita Pepo (Pumpkin) Fruit Extract, Helianthus Annuus (Sunflower) Extract, Inonotus Obliquus (Mushroom) Extract, Rhodiola Rosea Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Rhaponticum Carthamoides Root Extract, Selaginella Lepidophylla Extract, Rubus Idaeus (Raspberry) Seed Oil, Ribes Nigrum (Black Currant) Seed Oil, Mauritia Flexuosa Fruit Oil, Carthamus Tinctorius (Safflower) Seed Oil, Rubus Chamaemorus Seed Oil, Oryza Sativa (Rice) Bran Extract, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Tocopherol, Polyglyceryl-6 Behenate, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Fragrance (Parfum), Hydroxyacetophenone, Benzoic Acid, Chlorphenesin.
- Other Information
- Questions?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
NUTRICENTIALS DAY DREAM PROTECTIVE
homosalate, octisalate, avobenzone, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1555 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 80 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 40 mg in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Isodecyl Neopentanoate (UNII: W60VYE24XC) Pentylene Glycol (UNII: 50C1307PZG) Polyglyceryl-6 Stearate (UNII: ETY9Q81E2T) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Butyloctyl Salicylate (UNII: 2EH13UN8D3) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG) POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) Chlorphenesin (UNII: I670DAL4SZ) Ginger (UNII: C5529G5JPQ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Carnosine (UNII: 8HO6PVN24W) RICE BRAN (UNII: R60QEP13IC) Benzoic Acid (UNII: 8SKN0B0MIM) RIBES NIGRUM SEED OIL (UNII: GKE1188837) Mauritia Flexuosa Fruit Oil (UNII: 48H19MS04L) Xanthan Gum (UNII: TTV12P4NEE) RASPBERRY SEED OIL (UNII: 9S8867952A) Rubus Chamaemorus Seed Oil (UNII: WH495F04LZ) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) INONOTUS OBLIQUUS FRUITING BODY (UNII: MRO1FS760M) ELEUTHERO (UNII: ZQH6VH092Z) Rhaponticum Carthamoides Root (UNII: P8CUH2KYHL) Tocopherol (UNII: R0ZB2556P8) Rosemary (UNII: IJ67X351P9) SAFFLOWER OIL (UNII: 65UEH262IS) PUMPKIN (UNII: SYW0QUB89Y) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1555-1 1 in 1 CARTON 09/10/2020 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 09/10/2020 Labeler - NSE Products, Inc. (803486393)