Label: NUTRICENTIALS DAY DREAM PROTECTIVE- homosalate, octisalate, avobenzone, and octocrylene cream
- NDC Code(s): 62839-1554-1
- 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 September 23, 2020
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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), Polyglyceryl-6 Stearate, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Isodecyl Neopentanoate, Potassium Cetyl Phosphate, Triacontanyl PVP, Propanediol, Cetearyl Alcohol, Glycerin, Batyl Alcohol, Capsicum Annuum Fruit Extract, Oryza Sativa (Rice) Bran Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Selaginella Lepidophylla Extract, Rhaponticum Carthamoides Root Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Helianthus Annuus (Sunflower) Extract, Inonotus Obliquus (Mushroom) Extract, Bisabolol, Mauritia Flexuosa Fruit Oil, Rhodiola Rosea Extract, Tocopheryl Acetate, Tocopherol, Silica, Glyceryl Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyglyceryl-6 Behenate, Xanthan Gum, Disodium EDTA, Citric Acid, Sodium Hydroxide, Fragrance (Parfum), Sodium Dehydroacetate, Caprylhydroxamic Acid, Chlorphenesin, Phenoxyethanol.
- Other Information
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- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
NUTRICENTIALS DAY DREAM PROTECTIVE
homosalate, octisalate, avobenzone, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1554 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) Polyglyceryl-6 Stearate (UNII: ETY9Q81E2T) Butylene Glycol (UNII: 3XUS85K0RA) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Butyloctyl Salicylate (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Isodecyl Neopentanoate (UNII: W60VYE24XC) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) Propanediol (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Glycerin (UNII: PDC6A3C0OX) BATILOL (UNII: 39YR661C4U) PAPRIKA (UNII: X72Z47861V) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Phenoxyethanol (UNII: HIE492ZZ3T) Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG) Polyglyceryl-6 Behenate (UNII: 4T2L7QI313) RICE BRAN (UNII: R60QEP13IC) Caprylhydroxamic Acid (UNII: UPY805K99W) Chlorphenesin (UNII: I670DAL4SZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Xanthan Gum (UNII: TTV12P4NEE) LEVOMENOL (UNII: 24WE03BX2T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Mauritia Flexuosa Fruit Oil (UNII: 48H19MS04L) Sodium Dehydroacetate (UNII: 8W46YN971G) 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1554-1 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)
