baby mineral sunscreen + probiotics spf55+

baby mineral sunscreen + probiotics spf55+
SPL v2
SPL
SPL Set ID 0191b2e4-bcc5-541a-e063-6294a90a0e78
Route
topical
Published
Effective Date 2023-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-07-28
Purpose

Sunscreen

Description

Zinc Oxide 20.0%

Medication Information

Warnings

For external use only

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 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
  • For children under 6 months of age, ask a doctor
  • 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: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses
Other Information
  • Protect the product in this container from excessive heat and direct sun
  • Avoid long-term exposure storage above 40°C (104°F)
  • May stain some fabrics
Inactive Ingredients

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

*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%

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

Warnings

For external use only

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 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
  • For children under 6 months of age, ask a doctor
  • 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: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses
Other Information
  • Protect the product in this container from excessive heat and direct sun
  • Avoid long-term exposure storage above 40°C (104°F)
  • May stain some fabrics
Inactive Ingredients

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

*Organic

Questions?

(888)860-6888

Section 51945-4 (51945-4)

Do Not Use On (Do not use on)

broken or damaged skin

Active Ingredients

Zinc Oxide 20.0%

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:15.336872 · Updated: 2026-03-14T23:06:45.911086