zinc oxide sunscreen lotion

zinc oxide sunscreen lotion
SPL v4
SPL
SPL Set ID a74ec20b-8436-4030-820c-01fd88134f40
Route
topical
Published
Effective Date 2025-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (25 g)
Inactive Ingredients
water medium-chain triglycerides glycerin propanediol butyloctyl salicylate c13-15 alkane polyhydroxystearic acid (2300 mw) polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate c9-12 alkane isostearic acid isoamyl laurate lecithin, sunflower polyglyceryl-3 pentaricinoleate quaternium-90 bentonite cocoyl caprylocaprate caprylhydroxamic acid coconut vanilla bean sodium chloride ethyl vanillin 1,2-hexanediol galactoarabinan triethyl citrate .alpha.-tocopherol acetate ferric oxide yellow ferric oxide red ferrosoferric oxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-08-28

Purpose

Sunscreen

Description

Zinc oxide 25%


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

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

• apply generously and evenly 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

• children under 6 months of age: Ask a doctor

• apply to face and neck as the last step in your skincare routine

Other Information

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Butyloctyl Salicylate, C13-15 Alkane, Polyhydroxystearic Acid, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, C9-12 Alkane, Isostearic Acid, Isoamyl Laurate, Lecithin, Polyglyceryl-3 Polyricinoleate, Quaternium-90 Bentonite, Coco-Caprylate/Caprate, Caprylhydroxamic Acid, Cocos Nucifera (Coconut) Fruit Extract, Vanilla Planifolia Fruit Extract, Sodium Chloride, Ethyl Vanillin, 1,2-Hexanediol, Galactoarabinan, Triethyl Citrate, Tocopheryl Acetate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Description

Zinc oxide 25%

Section 42229-5

SAFE & CLEAN

Glow Pure Tinted Mineral SPF

Broad Spectrum SPF 40

CRUELTY-FREE

GLUTEN-FREE

DERMATOLOGIST RECOMMENDED

VEGAN

It's glow time

@gopurebeauty

We created goPure because we believe that everyone deserves to feel confident in their skin - Erin Keyan (goPure co-founder)

LET'S GLOW!

Manufactured for

goPure Beauty

3835 E.

Thousand Oaks

Suite R384

Westlake Village,

CA 91362

GOOD FACE PROJECT APPROVED

ANIMAL TEST-FREE

PeTA

www.gopurebeauty.com

FSC® C158805

FPO

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient

Zinc oxide 25%

Questions Or Comments?

+1-800-925-4232

You may also report serious side effects to this phone number. Monday - Friday 9:00 AM - 4:00 PM PST


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

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

• apply generously and evenly 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

• children under 6 months of age: Ask a doctor

• apply to face and neck as the last step in your skincare routine

Other Information (Other information)

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Butyloctyl Salicylate, C13-15 Alkane, Polyhydroxystearic Acid, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, C9-12 Alkane, Isostearic Acid, Isoamyl Laurate, Lecithin, Polyglyceryl-3 Polyricinoleate, Quaternium-90 Bentonite, Coco-Caprylate/Caprate, Caprylhydroxamic Acid, Cocos Nucifera (Coconut) Fruit Extract, Vanilla Planifolia Fruit Extract, Sodium Chloride, Ethyl Vanillin, 1,2-Hexanediol, Galactoarabinan, Triethyl Citrate, Tocopheryl Acetate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 42229-5 (42229-5)

SAFE & CLEAN

Glow Pure Tinted Mineral SPF

Broad Spectrum SPF 40

CRUELTY-FREE

GLUTEN-FREE

DERMATOLOGIST RECOMMENDED

VEGAN

It's glow time

@gopurebeauty

We created goPure because we believe that everyone deserves to feel confident in their skin - Erin Keyan (goPure co-founder)

LET'S GLOW!

Manufactured for

goPure Beauty

3835 E.

Thousand Oaks

Suite R384

Westlake Village,

CA 91362

GOOD FACE PROJECT APPROVED

ANIMAL TEST-FREE

PeTA

www.gopurebeauty.com

FSC® C158805

FPO

Section 50565-1 (50565-1)

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

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Zinc oxide 25%

Questions Or Comments? (Questions or comments?)

+1-800-925-4232

You may also report serious side effects to this phone number. Monday - Friday 9:00 AM - 4:00 PM PST


Advanced Ingredient Data


Raw Label Data

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