Damastique SPF Active Serum SPF 36
Damastique SPF Active Serum SPF 36
3cf69d31-f401-7f55-e063-6394a90a128a
HUMAN OTC DRUG LABEL
Aug 22, 2025
Damastíque
DUNS: 121894178
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ZINC OXIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (23)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Labeling:
INDICATIONS & USAGE SECTION
Uses
• Helps prevent sunburn
• If used as directed with other sun protection measures (seeDirections),
decreases the risk of skin cancer and early skin aging caused by the sun.
OTC - QUESTIONS SECTION
Questions?
www.damastique.com Email: suncare@damastique.com
SPL UNCLASSIFIED SECTION
Other Information
• Protect the product in this container from excessive heat and direct sun
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each dosage unit)
Zinc Oxide 20%
Purpose
Sunscreen
WARNINGS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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
INACTIVE INGREDIENT SECTION
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.