POWERBRIGHT MOISTURIZER SPF 50- octocrylene, homosalate, avobenzone, and octisalate lotion 
Dermalogica, LLC.

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.

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Powerbright Moisturizer SPF 50

Drug Facts

Active ingredient

Octocrylene 8.0%
Homosalate 5.0%
Avobenzone 3.0%
Octisalate 3.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

  • on damaged or broken skin.

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

  • if rash occurs.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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

Call toll free
1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

powerbright
moisturizer

SPF
50

broad spectrum

dark spot defense

1.7 US FL OZ / 50 mL e

dermalogica

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
POWERBRIGHT MOISTURIZER SPF 50 
octocrylene, homosalate, avobenzone, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene80 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate50 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-020-021 in 1 CARTON03/04/2021
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68479-020-0112 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2021
3NDC:68479-020-057 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2021
4NDC:68479-020-062 mL in 1 POUCH; Type 0: Not a Combination Product03/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/04/2021
Labeler - Dermalogica, LLC. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
McKenna090631412MANUFACTURE(68479-020)

Revised: 9/2022
Document Id: 1f4f1c23-f768-4643-b06e-dc8dcd62b399
Set id: 02c731ee-c5cb-4158-9b1f-e826593c3526
Version: 1
Effective Time: 20220901
 
Dermalogica, LLC.