SPL v3
SPL
SPL Set ID 1cd10158-c346-60c9-e063-6294a90a54bd
Route
TOPICAL
Published
Effective Date 2024-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17.68 g)
Inactive Ingredients
Tocopherol Caprylic/capric Triglyceride Glyceryl Citrate/lactate/linoleate/oleate Water Dicaprylyl Ether C13-15 Alkane Polyglyceryl-3 Pentaricinoleate Glycerin 1,2-hexanediol Disteardimonium Hectorite Isostearic Acid Squalane Bisabolol Lecithin, Soybean Polyhydroxystearic Acid (2300 Mw) Sorbitan Isostearate Coco-caprylate Vaccinium Macrocarpon (cranberry) Seed Oil Anhydroxylitol Xylitol Hedychium Coronarium Root Glucose Hectorite Ectoine Cetyl Alcohol Caprylyl Glycol Xylitylglucoside

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-08

Description

Zinc Oxide 17.68%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

Shake well. Apply generously to face and neck 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. For adult use only.

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.-2p.m ■ wear long-sleeved shirts, pants, hats, and sunglasses.

Description

Zinc Oxide 17.68%

Section 50565-1

Keep out of reach of children. If 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

WATER, DICAPRYLYL ETHER, CAPRYLIC/CAPRIC TRIGLYCERIDE, C13-15 ALKANE, POLYGLYCERYL-3 POLYRICINOLEATE, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, COCO-CAPRYLATE, SQUALANE, GLYCERIN, ECTOIN, BISABOLOL, CETYL ALCOHOL, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, HECTORITE, ISOSTEARIC ACID, LECITHIN, POLYHYDROXYSTEARIC ACID, SORBITAN ISOSTEARATE, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, XYLITOL, HEDYCHIUM CORONARIUM ROOT EXTRACT, TOCOPHEROL, GLUCOSE.

Section 51945-4

Section 53413-1

1 833 794 1705

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 17.68%

Section 60561-8

Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

Shake well. Apply generously to face and neck 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. For adult use only.

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.-2p.m ■ wear long-sleeved shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If 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)

WATER, DICAPRYLYL ETHER, CAPRYLIC/CAPRIC TRIGLYCERIDE, C13-15 ALKANE, POLYGLYCERYL-3 POLYRICINOLEATE, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, COCO-CAPRYLATE, SQUALANE, GLYCERIN, ECTOIN, BISABOLOL, CETYL ALCOHOL, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, HECTORITE, ISOSTEARIC ACID, LECITHIN, POLYHYDROXYSTEARIC ACID, SORBITAN ISOSTEARATE, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, XYLITOL, HEDYCHIUM CORONARIUM ROOT EXTRACT, TOCOPHEROL, GLUCOSE.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1 833 794 1705

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 17.68%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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