1c36a57a-55e6-e506-e063-6294a90acb04

SPL v4
SPL
SPL Set ID 1c36a57a-55e6-e506-e063-6294a90acb04
Route
topical
Published
Effective Date 2024-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (11.12 g)
Inactive Ingredients
hyaluronate sodium glycerin ethylhexylglycerin menadione butylene glycol dicaprylate/dicaprate tocopherol caprylyl glycol water dipropylene glycol caprylyl trisiloxane butylene glycol polyglyceryl-2 triisostearate cyclomethicone 6 butyloctyl salicylate propylheptyl caprylate disteardimonium hectorite triethoxycaprylylsilane 1,2-hexanediol medium-chain triglycerides centella asiatica triterpenoids

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-09

Purpose

Sunscreen

Description

ZINC OXIDE (22.24%)


Medication Information

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 rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Sunscreen

Directions

For sunscreen use:

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-resistant shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Inactive Ingredients

WATER, CYCLOHEXASILOXANE, CAPRYLYL METHICONE, BUTYLENE GLYCOL, DICAPRYLATE/DICAPRATE, BUTYLOCTYL SALICYLATE, DIPROPYLENE GLYCOL, PROPYLHEPTYL CAPRYLATE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, POLYGLYCERYL-2 TRIISOSTEARATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, FRAGRANCE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, SODIUM HYALURONATE, TOCOPHEROL, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYGLYCERYL-10 DIISOSTEARATE, HYDROGENATED LECITHIN, MENADIONE, CENTELLA ASIATICA EXTRACT, BETA-GLUCAN

Description

ZINC OXIDE (22.24%)

Section 51945-4

Active Ingredient

ZINC OXIDE (22.24%)

Keep Out of Reach of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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 rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Sunscreen

Directions

For sunscreen use:

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-resistant shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Inactive Ingredients

WATER, CYCLOHEXASILOXANE, CAPRYLYL METHICONE, BUTYLENE GLYCOL, DICAPRYLATE/DICAPRATE, BUTYLOCTYL SALICYLATE, DIPROPYLENE GLYCOL, PROPYLHEPTYL CAPRYLATE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, POLYGLYCERYL-2 TRIISOSTEARATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, FRAGRANCE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, SODIUM HYALURONATE, TOCOPHEROL, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYGLYCERYL-10 DIISOSTEARATE, HYDROGENATED LECITHIN, MENADIONE, CENTELLA ASIATICA EXTRACT, BETA-GLUCAN

Section 51945-4 (51945-4)

Active Ingredient

ZINC OXIDE (22.24%)

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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