PORESCREEN SPF40- zinc oxide lotion

PORESCREEN SPF40 by

Drug Labeling and Warnings

PORESCREEN SPF40 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, LLC., Nanophase Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zinc Oxide (10%)

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

• Shake before each use. Apply evenly and liberally to face, 15 minutes prior to sun exposure. Can be worn alone or underneath make-up.
• Reapply at least every two hours.
• Use a water-resistant sunscreen if swimming or sweating.
• 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 of age: Ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Isododecane, Lauryl PEG-8 Dimethicone, Propanediol, Niacinamide, Methylpropanediol, Titanium Dioxide (CI 77891), Silica Silylate, Lactic Acid, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosa Damascena Extract, Chlorella Vulgaris Extract, Sea Salt (Maris Sal), Olive Oil Decyl Esters, Squalene, Tocopherol, Caprylyl Glycol, Lecithin, Allantoin, Propylene Glycol Stearate, Glycerin, Bisabolol, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, PEG-10, Silica, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Magnesium Stearate, Tetrasodium Glutamate Diacetate, Citric Acid, Sodium Hydroxide, Sodium Chloride, Bentonite, Cellulose Acetate, Phenylpropanol, Hydrated Silica, Acrylates/Ammonium Methacrylate Copolymer, Iron Oxides (CI 77491, CI 77492, CI 77499), Linalool.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

dermalogica

porescreen

SPF
40

high
protection

UVA
UVB

broad spectrum

with
niacinamide

blurring + hint of tint
mineral sunscreen

Sun Care

1.0 US FL OZ / 30 mL ℮

INGREDIENTS AND APPEARANCE

PORESCREEN SPF40 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-291
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	10 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Isododecane (UNII: A8289P68Y2)
Propanediol (UNII: 5965N8W85T)
Methylpropanediol (UNII: N8F53B3R4R)
Niacinamide (UNII: 25X51I8RD4)
Titanium Dioxide (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate (UNII: 687U3PEB2Y)
Sodium Chloride (UNII: 451W47IQ8X)
Bentonite (UNII: A3N5ZCN45C)
Caprylyl Glycol (UNII: 00YIU5438U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
Allantoin (UNII: 344S277G0Z)
Cellulose Acetate (UNII: 3J2P07GVB6)
Olive Oil Decyl Esters (UNII: 3AQ222F18X)
Phenylpropanol (UNII: 0F897O3O4M)
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
Magnesium Stearate (UNII: 70097M6I30)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Hydrated Silica (UNII: Y6O7T4G8P9)
POLYETHYLENE OXIDE 200000 (UNII: 11628IH70O)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
LEVOMENOL (UNII: 24WE03BX2T)
Squalene (UNII: 7QWM220FJH)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
ROSA X ALBA FLOWER OIL (UNII: FF1Y064QVO)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
Sea Salt (UNII: 87GE52P74G)
Sodium Hydroxide (UNII: 55X04QC32I)
Tocopherol (UNII: R0ZB2556P8)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-291-02	1 in 1 CARTON	12/01/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-291-04	59 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2022
3	NDC: 68479-291-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/01/2022

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies		623502044	MANUFACTURE(68479-291)