1cd10158-c346-60c9-e063-6294a90a54bd

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.

Active Ingredient

Zinc Oxide 17.68%

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 60561-8

Protect this product from excessive heat and direct sun.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Zinc Oxide 17.68%

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.

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 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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