Label: POWERBRIGHT MOISTURIZER SPF 50- octocrylene, homosalate, avobenzone, and octisalate lotion
- NDC Code(s): 68479-020-01, 68479-020-02, 68479-020-05, 68479-020-06
- Packager: Dermalogica, 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 September 1, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 30 minutes before sun exposure.
- Reapply at least every two hours.
- Use a water resistant sunscreen if swimming or sweating.
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help 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-sleeve shirts, pants, hats and sunglasses.
- Children under 6 months: ask a doctor.
- Other information
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Inactive ingredients
Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, C12-15 Alkyl Benzoate, Niacinamide, Polysorbate 80, Laminaria Digitata Extract, Lavandula Hybrida Oil, Lavandula Angustifolia (Lavender) Flower Extract, Cananga Odorata Flower Oil, Eucalyptol, Glycerin, Pentylene Glycol, PPG-12/SMDI Copolymer, Bisabolol, Ethylhexylglycerin, Caprylyl Glycol, Glycogen, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Gluconolactone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Polyacrylate, Propanediol, Trisodium Ethylenediamine Disuccinate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Polymethylsilsesquioxane, Silica, Sodium Benzoate, Sodium Hydroxide, Benzyl Benzoate, Benzyl Salicylate, Farnesol, Limonene, Linalool, Geraniol, Isoeugenol.
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
POWERBRIGHT MOISTURIZER SPF 50
octocrylene, homosalate, avobenzone, and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 80 mg in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 50 mg in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) SAFFLOWER OIL (UNII: 65UEH262IS) Butylene Glycol (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Niacinamide (UNII: 25X51I8RD4) Polysorbate 80 (UNII: 6OZP39ZG8H) Glycerin (UNII: PDC6A3C0OX) Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG) Pentylene Glycol (UNII: 50C1307PZG) Propanediol (UNII: 5965N8W85T) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PPG-12/Smdi Copolymer (UNII: 1BK9DDD24E) Caprylyl Glycol (UNII: 00YIU5438U) Glycogen (UNII: 309GSC92U1) LAVANDIN OIL (UNII: 9RES347CKG) YLANG-YLANG LEAF OIL (UNII: 6W864D0X3X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LEVOMENOL (UNII: 24WE03BX2T) Gluconolactone (UNII: WQ29KQ9POT) Ethylhexylglycerin (UNII: 147D247K3P) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q) Sodium Benzoate (UNII: OJ245FE5EU) Sodium Hydroxide (UNII: 55X04QC32I) LAMINARIA DIGITATA (UNII: 15E7C67EE8) Eucalyptol (UNII: RV6J6604TK) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) LINALOOL, (+/-)- (UNII: D81QY6I88E) Benzyl Benzoate (UNII: N863NB338G) Benzyl Salicylate (UNII: WAO5MNK9TU) Farnesol (UNII: EB41QIU6JL) LIMONENE, (+)- (UNII: GFD7C86Q1W) Geraniol (UNII: L837108USY) Isoeugenol (UNII: 5M0MWY797U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-020-02 1 in 1 CARTON 03/04/2021 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68479-020-01 12 mL in 1 TUBE; Type 0: Not a Combination Product 03/04/2021 3 NDC:68479-020-05 7 mL in 1 TUBE; Type 0: Not a Combination Product 03/04/2021 4 NDC:68479-020-06 2 mL in 1 POUCH; Type 0: Not a Combination Product 03/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/04/2021 Labeler - Dermalogica, LLC. (177698560) Establishment Name Address ID/FEI Business Operations McKenna 090631412 MANUFACTURE(68479-020)
