Mineral Sunscreen Spf 50

Mineral Sunscreen Spf 50
SPL v4
SPL
SPL Set ID 1d8e727c-8b50-9cf2-e063-6394a90a2e15
Route
TOPICAL
Published
Effective Date 2025-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22 g)
Inactive Ingredients
Glycerin Betasizofiran Aceneuramic Acid Anhydrous Citric Acid Xanthan Gum Medium-chain Triglycerides Cetostearyl Alcohol Sorbitan Sesquioleate Sunflower Oil Hyaluronate Sodium Levomenol Glyceryl Stearate Se Isoamyl Laurate Glyceryl Caprylate Lysophosphatidylcholine, Soybean Aloe Vera Leaf .alpha.-tocopherol Acetate, D- Polyhydroxystearic Acid (2300 Mw) Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Water Hydrolyzed Jojoba Esters (acid Form) Pullulan Sodium Stearoyl Glutamate Coco-glucoside Caprylhydroxamic Acid Squalane Jojoba Oil Butyloctyl Salicylate Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

Zinc Oxide 22%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 22%

Uses

• helps prevent sunburn

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 the product keep out of eyes. Rinse with water to remove.

Section 50570-1

• Do not use on damaged or broken skin.

Section 51945-4

Warnings

• For external use

Directions

Directions_• apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water-resistant sunscreen if swimming or sweating. • 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 a.m.-2 p.m.

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

Questions?

Call toll-free 877.902.2873

Other Information

Protect this product from excessive heat and direct sun.

May stain some

Active Ingredients

Zinc Oxide 22%

Inactive Ingredients

ALOE BARBADENSIS LEAF JUICE*, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYESTER-8, GLYCERIN, WATER, CETEARYL ALCOHOL, GLYCERYL STEARATE, SQUALANE, ISOAMYL LAURATE, SORBITAN SESQUIOLEATE, TOCOPHEROL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, HELANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM HYALURONATE, HYDROLYZED JOJOBA ESTERS, BISABOLOL, PULLULAN, SCLEROTIUM GUM, XANTHAN GUM, GLYCOLIPIDS, GLYCERYL CAPRYLATE, SODIUM STEAROYL GLUTAMATE, POLYHYDROXYSTEARIC ACID, COCO-GLUCOSIDE, LYSOLECITHIN, SILICA, CAPRYLHYDROXAMIC ACID, CITRIC ACID


Structured Label Content

Uses

• helps prevent sunburn

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 the product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

• Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

• For external use

Directions

Directions_• apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water-resistant sunscreen if swimming or sweating. • 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 a.m.-2 p.m.

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

Questions?

Call toll-free 877.902.2873

Other Information (Other information)

Protect this product from excessive heat and direct sun.

May stain some

Active Ingredients (Active ingredients)

Zinc Oxide 22%

Inactive Ingredients

ALOE BARBADENSIS LEAF JUICE*, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYESTER-8, GLYCERIN, WATER, CETEARYL ALCOHOL, GLYCERYL STEARATE, SQUALANE, ISOAMYL LAURATE, SORBITAN SESQUIOLEATE, TOCOPHEROL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, HELANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM HYALURONATE, HYDROLYZED JOJOBA ESTERS, BISABOLOL, PULLULAN, SCLEROTIUM GUM, XANTHAN GUM, GLYCOLIPIDS, GLYCERYL CAPRYLATE, SODIUM STEAROYL GLUTAMATE, POLYHYDROXYSTEARIC ACID, COCO-GLUCOSIDE, LYSOLECITHIN, SILICA, CAPRYLHYDROXAMIC ACID, CITRIC ACID


Advanced Ingredient Data


Raw Label Data

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