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

Powerbright Moisturizer SPF 50 by

Drug Labeling and Warnings

Powerbright Moisturizer SPF 50 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, LLC., McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purpose

Sunscreen

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

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

• Apply liberally 30 minutes before sun exposure.
• Reapply at least every two 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 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

• Protect this product from excessive heat and direct sun.

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

INGREDIENTS AND APPEARANCE

POWERBRIGHT MOISTURIZER SPF 50 
octocrylene, homosalate, avobenzone, and octisalate lotion

Product 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)