Porescreen Spf40 Lotion
FDA Label NDC 68479-291

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermalogica, Llc. for the product Porescreen Spf40 (NDC 68479-291). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 30 Ml Tube Carton

Other

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.

Otc - Keep Out Of Reach Of Children

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.