Baby Mineral Sunscreen Spf55+

Baby Mineral Sunscreen Spf55+
SPL v2
SPL
SPL Set ID 0190eeaf-c5a0-3253-e063-6294a90a43c4
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
Levomenol Butyloctyl Salicylate Caprylhydroxamic Acid Cetostearyl Alcohol Cetyl Alcohol Chamomile Orange Oil Diheptyl Succinate Polyhydroxystearic Acid Stearate Apricot Kernel Oil Sodium Gluconate Hyaluronate Sodium Sodium Stearoyl Glutamate Tocopherol Vanilla Bean Water Microcrystalline Cellulose Green Tea Leaf Arachidyl Alcohol Docosanol Cocoa Butter Arachidyl Glucoside Calendula Officinalis Flower Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Caprylyl Glycol Carboxymethylcellulose Sodium Citric Acid Monohydrate Coco Glucoside Coconut Oil Cucumber Glycerin Methyl Dihydroabietate Avocado Triethyl Citrate Shea Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-28
Description

Zinc Oxide 20.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20.0%

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
Section 51945-4

Warnings

For external use only

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
  • 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:
    • Limiting time in the sun, especially from 10a.m. - 2p.m.
    • Wearing long-sleeved shirts, pants, hats and sunglasses
Do Not Use On

broken or damaged skin

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
Active Ingredients

Zinc Oxide 20.0%

Inactive Ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis 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

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
Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

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
  • 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:
    • Limiting time in the sun, especially from 10a.m. - 2p.m.
    • Wearing long-sleeved shirts, pants, hats and sunglasses
Do Not Use On (Do not use on)

broken or damaged skin

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
Active Ingredients

Zinc Oxide 20.0%

Inactive Ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis 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

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: 2026-02-15T12:05:15.335500 · Updated: 2026-03-14T23:06:45.911086