Perfectint Powder Spf 40 (69219-111)

Perfectint Powder Spf 40 (69219-111)
SPL v4
SPL
SPL Set ID bb26c010-299e-3dc5-e053-2995a90a2c89
Route
TOPICAL
Published
Effective Date 2021-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (25 g)
Inactive Ingredients
Ferric Oxide Yellow Triethoxycaprylylsilane Mica Calcium Aluminum Borosilicate Sodium Anisate Lycopodium Clavatum Whole Capryloyl Glycine Tribasic Calcium Phosphate Imperata Cylindrica Root Glycerin Ferrosoferric Oxide Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-19

Description

Zinc Oxide 25%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Apply liberally 15 minutes before sun exposure

Dosage and Administration

Apply liberally 15 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Sun Protection Measures. Spending time in the sun increase 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 10am - 2pm.

wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Description

Zinc Oxide 25%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes.

Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, Calcium Sodium Borosilicate, Hydroxyapatite, Methyl Methacrylate Crosspolymer, Sodium Anisate, Lycopodium Clavatum Extract, Imperata Cylindrica Root Extract, Capryloyl Glycine, Glycerin, Triethoxycaprylylsiliane, Ironxe Oxides(CI 77491*, CI 77499*, CI77492*). *may contain one or more of these ingredients

Section 51945-4

Section 53413-1

Call Customer Care at (888)-804-4447

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 25%

Section 60561-8

Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Apply liberally 15 minutes before sun exposure

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Sun Protection Measures. Spending time in the sun increase 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 10am - 2pm.

wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes.

Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, Calcium Sodium Borosilicate, Hydroxyapatite, Methyl Methacrylate Crosspolymer, Sodium Anisate, Lycopodium Clavatum Extract, Imperata Cylindrica Root Extract, Capryloyl Glycine, Glycerin, Triethoxycaprylylsiliane, Ironxe Oxides(CI 77491*, CI 77499*, CI77492*). *may contain one or more of these ingredients

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call Customer Care at (888)-804-4447

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 25%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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