Damastique Spf Active Serum Spf 36 Emulsion
FDA Label NDC 87035-027

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Damast�que for the product Damastique Spf Active Serum Spf 36 (NDC 87035-027). 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 active ingredient (in each dosage unit), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out or reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Dosage Unit)

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases 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 Or Reach Of Children.

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

Other Warnings

• Perform a patch test before full application
• Discontinue use if irritation, redness, or discomfort develops
• Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Directions

• Apply generously and evenly 15 minutes before sun exposure.
• Children under 6 months of age: Ask a doctor.
• Sun Protection Measure:Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Store in cool, dry place away from sunlight
• Apply to all skin exposed to the sun
• Shake well
• Use after applying moisturizer, but before makeup

Other Information

• Protect the product in this container from excessive heat and direct sun

Inactive Ingredients:

Aloe Vera (Aloe Barbadensis) leaf juice, Zinc Oxide, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Isoamyl Laurate, Acai (Euterpe Oleracea Fruit) oil, Ethoxydiglycol, Ascorbyl Glucoside, Polyhydroxystearic Acid, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Propanediol, C13-15 Alkane, Magnesium Sulfate, Glyceryl Caprylate, Caramel, Passiflora Edulis Seed Oil, Polyglyceryl-3 Polyricinoleate,  Disteardimonium Hectorite, Glycerin, Sodium Chloride, Polyglyceryl-6 Xanthan Gum, Bisabolol, Caprylhydroxamic Acid, Tocopherol, Heterotheca Inuloides Flower Extract, Citric Acid.

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

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