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Damastique SPF Active Serum SPF 36

Damastique SPF Active Serum SPF 36

Approved
Approval ID

3cf69d31-f401-7f55-e063-6394a90a128a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 22, 2025

Manufacturers
FDA

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
NDC Product Code87035-027
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 22, 2025
FDA Product Classification

INGREDIENTS (23)

ALOE VERA LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
DICAPRYLYL CARBONATEInactive
Code: 609A3V1SUA
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
ISOAMYL LAURATEInactive
Code: M1SLX00M3M
Classification: IACT
ACAI OILInactive
Code: Z0W6766A2W
Classification: IACT
ETHOXYDIGLYCOLInactive
Code: A1A1I8X02B
Classification: IACT
ASCORBYL GLUCOSIDEInactive
Code: 2V52R0NHXW
Classification: IACT
POLYGLYCERYL-6 POLYRICINOLEATEInactive
Code: YPM0ZOC2HR
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
C13-15 ALKANEInactive
Code: 114P5I43UJ
Classification: IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMInactive
Code: DE08037SAB
Classification: IACT
GLYCERYL MONOCAPRYLATEInactive
Code: TM2TZD4G4A
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
PASSIFLORA EDULIS SEED OILInactive
Code: F3VOA31UHQ
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LEVOMENOLInactive
Code: 24WE03BX2T
Classification: IACT
CAPRYLHYDROXAMIC ACIDInactive
Code: UPY805K99W
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
HETEROTHECA INULOIDES FLOWERInactive
Code: W9NZ9OZF68
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ZINC OXIDEActive
Quantity: 200 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/22/2025

Package Labeling:

Inner PackageBottle

Outer Package

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/22/2025

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

LOINC: 53413-1Updated: 5/22/2025

Questions?

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/22/2025

Other Information

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/22/2025

Active Ingredient (in each dosage unit)

Zinc Oxide 20%

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 5/22/2025

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

LOINC: 34068-7Updated: 5/22/2025

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

LOINC: 51727-6Updated: 5/22/2025

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.

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