Label: PORESCREEN SPF40- zinc oxide lotion
- NDC Code(s): 68479-291-02, 68479-291-04, 68479-291-05
- 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 December 21, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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
- 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
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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?
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
PORESCREEN SPF40
zinc oxide lotionProduct 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)
