DAMASTIQUE SPF ACTIVE SERUM SPF 36- zinc oxide emulsion

Damastique SPF Active Serum SPF 36 by

Drug Labeling and Warnings

Damastique SPF Active Serum SPF 36 by is a Otc medication manufactured, distributed, or labeled by Damastíque, Orean Personal Care Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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.

Questions?

www.damastique.com Email: suncare@damastique.com

Package Labeling:

INGREDIENTS AND APPEARANCE

DAMASTIQUE SPF ACTIVE SERUM SPF 36 
zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87035-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
ACAI OIL (UNII: Z0W6766A2W)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
PROPANEDIOL (UNII: 5965N8W85T)
C13-15 ALKANE (UNII: 114P5I43UJ)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
CARAMEL (UNII: T9D99G2B1R)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TOCOPHEROL (UNII: R0ZB2556P8)
HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87035-027-01	1 in 1 CARTON	05/05/2025
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/05/2025

Labeler - Damastíque (121894178)

Establishment
Name	Address	ID/FEI	Business Operations
Orean Personal Care Ltd.		211403363	manufacture(87035-027)