naked sundays glow balm mineral peptide stick broad spectrum spf50 dusky pink 8g

naked sundays glow balm mineral peptide stick broad spectrum spf50 dusky pink 8g
SPL v4
SPL
SPL Set ID 2f441311-b41c-d4e8-e063-6394a90a697a
Route
topical
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (23.75 g)
Inactive Ingredients
ceresin ci 77491 stearalkonium hectorite copernicia cerifera (carnauba) wax theobroma cacao (cocoa) seed butter palmitoyl hexapeptide-12 ci 77499 coco-caprylate/caprate c12-15 alkyl benzoate .alpha.-tocopherol acetate tapioca starch polyglyceryl-3 pentaricinoleate isostearic acid ricinus communis (castor) seed oil pentaerythrityl tetraisostearate euphorbia cerifera (candelilla) wax ferric oxide yellow propylene carbonate caprylic/capric triglyceride

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-01

Description

Zinc Oxide 23.75 %


Medication Information

Warnings and Precautions

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 skin rash occurs.

Keep out of reach of children. If

product is swallowed, get medical

help or contact a Poison Control

Center right away.

Indications and Usage

Use: Helps prevent sunburn. If

used as directed with other sun

protection measures (see directions),

decreases the risk of skin cancer and

early skin ageing caused by the sun.

Dosage and Administration

Directions: Apply liberally and

evenly 15 minutes before sun

exposure. Reapply at least every 2

hours or immediately after swimming,

sweating or towel drying. Use a

water-resistance sunscreen if

swimming or sweating.

Description

Zinc Oxide 23.75 %

Section 50565-1

Keep out of reach of children.

Section 51727-6

INACTIVE INGREDIENTS: C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Iron Oxides (CI77491, CI77492, CI 77499), Isostearic Acid, Palmitoyl Hexapeptide-12, Pentaerythrityl Tetraisostearate, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Ricinus Communis (Castor) Seed Oil, Stearalkonium Hectorite, Tapioca Starch, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate,OZOKERITE

Section 51945-4

Section 53413-1

Questions:

[email protected]

Section 54433-8

Directions: Apply liberally and

evenly 15 minutes before sun

exposure. Reapply at least every 2

hours or immediately after swimming,

sweating or towel drying. Use a

water-resistance sunscreen if

swimming or sweating. Children

under 6 months of age: Ask a Doctor

Sun Protection Measures: 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

10.00AM - 2.00PM Wear

long-sleeved shirts, pants, hats, and

sunglasses.

Section 55105-1

SPF Sunscreen

Section 60561-8

Other Information:

Protect this product from excess

heat and direct sun.

Store below 30°C / 86°F

Active Ingredients:

Zinc Oxide 23.75 %


Structured Label Content

Warnings and Precautions (34071-1)

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 skin rash occurs.

Keep out of reach of children. If

product is swallowed, get medical

help or contact a Poison Control

Center right away.

Indications and Usage (34067-9)

Use: Helps prevent sunburn. If

used as directed with other sun

protection measures (see directions),

decreases the risk of skin cancer and

early skin ageing caused by the sun.

Dosage and Administration (34068-7)

Directions: Apply liberally and

evenly 15 minutes before sun

exposure. Reapply at least every 2

hours or immediately after swimming,

sweating or towel drying. Use a

water-resistance sunscreen if

swimming or sweating.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Iron Oxides (CI77491, CI77492, CI 77499), Isostearic Acid, Palmitoyl Hexapeptide-12, Pentaerythrityl Tetraisostearate, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Ricinus Communis (Castor) Seed Oil, Stearalkonium Hectorite, Tapioca Starch, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate,OZOKERITE

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions:

[email protected]

Section 54433-8 (54433-8)

Directions: Apply liberally and

evenly 15 minutes before sun

exposure. Reapply at least every 2

hours or immediately after swimming,

sweating or towel drying. Use a

water-resistance sunscreen if

swimming or sweating. Children

under 6 months of age: Ask a Doctor

Sun Protection Measures: 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

10.00AM - 2.00PM Wear

long-sleeved shirts, pants, hats, and

sunglasses.

Section 55105-1 (55105-1)

SPF Sunscreen

Section 60561-8 (60561-8)

Other Information:

Protect this product from excess

heat and direct sun.

Store below 30°C / 86°F

Active Ingredients:

Zinc Oxide 23.75 %


Advanced Ingredient Data


Raw Label Data

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