mineral sunscreen lotion spf50

mineral sunscreen lotion spf50
SPL v2
SPL
SPL Set ID 01cc205b-a345-262a-e063-6394a90a955c
Route
topical
Published
Effective Date 2023-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (200 mg)
Inactive Ingredients
arachidyl alcohol arachidyl glucoside docosanol levomenol butyloctyl salicylate shea butter calendula officinalis flower green tea leaf caprylhydroxamic acid capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) caprylyl glycol carboxymethylcellulose sodium cetostearyl alcohol cetyl alcohol chamomile citric acid monohydrate orange oil coco glucoside coconut oil cucumber diheptyl succinate glycerin methyl dihydroabietate microcrystalline cellulose avocado polyhydroxystearic acid stearate apricot kernel oil sodium gluconate hyaluronate sodium sodium stearoyl glutamate cocoa butter tocopherol triethyl citrate vanilla bean water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-07-30
Purpose

Sunscreen

Description

Zinc Oxide 20.0%

Medication Information

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

Shake well before use

Apply liberally and spread evenly by hand 15 minutes before sun exposure

Reapply:

  • after 80 minutes of swimming or sweating immediately after towel use
  • at least every 2 hours

Sun Protection Measures

Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limiting time in the sun, especially from 10a.m. - 2p.m.
  • Wearing long-sleeved shirts, pants, hats and sunglasses

Children under six months: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun

Avoid long-term exposure storage above 40°C (104°F)

May stain some fabrics

Inactive Ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco Glucoside, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Fruit Extract*, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Persea Gratissima (Avocado) Fruit Extract*, Polyhydroxystearic Acid, Prunus Armeniaca (Apricot) Kernel Oil*, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water (Aqua) *Organic

Description

Zinc Oxide 20.0%

Questions?

(888)860-6888

Section 51945-4

Do Not Use

on broken or damaged skin

Active Ingredients

Zinc Oxide 20.0%

For External Use Only

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 swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

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

Shake well before use

Apply liberally and spread evenly by hand 15 minutes before sun exposure

Reapply:

  • after 80 minutes of swimming or sweating immediately after towel use
  • at least every 2 hours

Sun Protection Measures

Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limiting time in the sun, especially from 10a.m. - 2p.m.
  • Wearing long-sleeved shirts, pants, hats and sunglasses

Children under six months: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun

Avoid long-term exposure storage above 40°C (104°F)

May stain some fabrics

Inactive Ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco Glucoside, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Fruit Extract*, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Persea Gratissima (Avocado) Fruit Extract*, Polyhydroxystearic Acid, Prunus Armeniaca (Apricot) Kernel Oil*, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water (Aqua) *Organic

Questions?

(888)860-6888

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on broken or damaged skin

Active Ingredients

Zinc Oxide 20.0%

For External Use Only (For external use only)

When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

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

If swallowed, get medical help or contact a Poison Control Center right away.

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:15.338401 · Updated: 2026-03-14T23:06:45.911086