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

naked sundays glow balm mineral peptide stick broad spectrum spf50 bronze 8g
SPL v3
SPL
SPL Set ID 2f42d22a-983e-d304-e063-6294a90a3719
Route
topical
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (22.1 g)
Inactive Ingredients
butyloctyl salicylate palmitoyl hexapeptide-12 isostearic acid silica dimethyl silylate caprylyl glycol diisostearyl malate bis-diglyceryl polyacyladipate-2 sodium hyaluronate hexylene glycol ethylhexyl palmitate brown iron oxide coco-caprylate/caprate stearalkonium hectorite phenyl trimethicone polyglyceryl-3 pentaricinoleate butylene glycol caprylic/capric triglyceride ethylhexyl methoxycrylene phenoxyethanol propylene carbonate persea gratissima (avocado) oil butyrospermum parkii (shea) butter mica silica euphorbia cerifera (candelilla) wax ceresin dextrin palmitate (corn; 20000 mw) pentaerythrityl tetraisostearate cocos nucifera (coconut) oil

Identifiers & Packaging

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

Description

Zinc Oxide 22.1 %


Medication Information

Uses

SPF Product

Indications and Usage

Uses: 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: Shake well before use.

Apply liberally and reapply every 80 minutes,

especially after swimming or towel drying.

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 am-2 pm Wear longsleeved

shirts, pants, hats, and sunglasses For

Children under 6 months of age ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENTS: Bis-Diglyceryl Polyacyladipate-2, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Coco-Caprylate/Caprate, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Diisostearyl Malate, Ethylhexyl Methoxycrylene, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax, Hexylene Glycol, Iron Oxides, Isostearic acid, Mica, Ozokerite, Palmitoyl Hexapeptide‐12, Pentaerythrityl Tetraisostearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Silica, Silica Dimethyl Silylate, Sodium Hyaluronate, Stearalkonium Hectorite

Description

Zinc Oxide 22.1 %

Section 50565-1

Warnings: For external use only. Do not use

on damaged or broken skin Avoid prolonged

sun exposure. If it gets in your eyes, wash well

with water. Keep out of reach of children.

Stop use and ask a doctor if rashes occur.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51945-4

Section 53413-1

Questions: [email protected]

Warning

Warnings: For external use only. Do not use

on damaged or broken skin Avoid prolonged

sun exposure. If it gets in your eyes, wash well

with water. Keep out of reach of children.

Stop use and ask a doctor if rashes occur.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Active Ingredients

Zinc Oxide 22.1 %

Other Information:

Other Information: Protect this product

from excess heat and direct sun. Store below

30°C / 86°F.


Structured Label Content

Uses (uses)

SPF Product

Indications and Usage (34067-9)

Uses: 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: Shake well before use.

Apply liberally and reapply every 80 minutes,

especially after swimming or towel drying.

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 am-2 pm Wear longsleeved

shirts, pants, hats, and sunglasses For

Children under 6 months of age ask a doctor.

Inactive Ingredients (INACTIVE INGREDIENTS)

INACTIVE INGREDIENTS: Bis-Diglyceryl Polyacyladipate-2, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Coco-Caprylate/Caprate, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Diisostearyl Malate, Ethylhexyl Methoxycrylene, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax, Hexylene Glycol, Iron Oxides, Isostearic acid, Mica, Ozokerite, Palmitoyl Hexapeptide‐12, Pentaerythrityl Tetraisostearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Silica, Silica Dimethyl Silylate, Sodium Hyaluronate, Stearalkonium Hectorite

Section 50565-1 (50565-1)

Warnings: For external use only. Do not use

on damaged or broken skin Avoid prolonged

sun exposure. If it gets in your eyes, wash well

with water. Keep out of reach of children.

Stop use and ask a doctor if rashes occur.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions: [email protected]

Warning

Warnings: For external use only. Do not use

on damaged or broken skin Avoid prolonged

sun exposure. If it gets in your eyes, wash well

with water. Keep out of reach of children.

Stop use and ask a doctor if rashes occur.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Active Ingredients

Zinc Oxide 22.1 %

Other Information:

Other Information: Protect this product

from excess heat and direct sun. Store below

30°C / 86°F.


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Raw Label Data

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