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

naked sundays glow balm mineral peptide stick broad spectrum spf50 pink pop 8g
SPL v3
SPL
SPL Set ID 2f46049b-7e81-9c7e-e063-6394a90a8f49
Route
topical
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (22.75 g)
Inactive Ingredients
propylene carbonate ci 14700 tin oxide stearalkonium hectorite mica polyglyceryl-3 pentaricinoleate caprylic/capric triglyceride euphorbia cerifera (candelilla) wax titanium dioxide pentaerythrityl tetraisostearate theobroma cacao (cocoa) seed butter c12-15 alkyl benzoate fd&c yellow no. 6 aluminum lake palmitoyl hexapeptide-12 isostearic acid .alpha.-tocopherol acetate coco-caprylate/caprate copernicia cerifera (carnauba) wax ricinus communis (castor) seed oil ceresin

Identifiers & Packaging

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

Description

Zinc Oxide 22.75%


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.

Active Ingredient

Zinc Oxide 22.75%

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. Children

under 6 months of age: Ask a Doctor

Description

Zinc Oxide 22.75%

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, FD&C Red No. 4 (CI 14700), FD&C Yellow 6 Lake (CI 15985:1), Isostearic Acid, Mica, Microcrystalline Wax, Palmitoyl Hexapeptide-12, Paraffin Wax, Pentaerythrityl Tetraisostearate, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Ricinus Communis (Castor) Seed Oil, Stearalkonium Hectorite, Theobroma Cacao (Cocoa) Seed Butter, Tin Oxide, Titanium Dioxide (CI 77891), Tocopheryl Acetate

Section 51945-4

Section 55105-1

SPF Suncscreen

Section 60561-8

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.


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.

Active Ingredient (55106-9)

Zinc Oxide 22.75%

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. Children

under 6 months of age: Ask a Doctor

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, FD&C Red No. 4 (CI 14700), FD&C Yellow 6 Lake (CI 15985:1), Isostearic Acid, Mica, Microcrystalline Wax, Palmitoyl Hexapeptide-12, Paraffin Wax, Pentaerythrityl Tetraisostearate, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Ricinus Communis (Castor) Seed Oil, Stearalkonium Hectorite, Theobroma Cacao (Cocoa) Seed Butter, Tin Oxide, Titanium Dioxide (CI 77891), Tocopheryl Acetate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

SPF Suncscreen

Section 60561-8 (60561-8)

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.


Advanced Ingredient Data


Raw Label Data

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