Babo Botanicals Sensitive Baby Mineral Sunscreen Spf50

Babo Botanicals Sensitive Baby Mineral Sunscreen Spf50
SPL v2
SPL
SPL Set ID 08a175ae-2307-ef8d-e063-6394a90ad234
Route
TOPICAL
Published
Effective Date 2020-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Calendula Officinalis Flower Cetostearyl Alcohol Hyaluronate Sodium Sodium Stearoyl Glutamate Tocopherol Levomenol Glycerin Water Nasturtium Officinale Flowering Top Polyhydroxystearic Acid (2300 Mw) Sodium Gluconate Cetyl Alcohol Citric Acid Monohydrate Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Form Chamomile Butyloctyl Salicylate Arachidyl Alcohol Arachidyl Glucoside Docosanol Shea Butter Caprylhydroxamic Acid Methyl Dihydroabietate Coco Glucoside Coconut Oil Sunflower Oil Microcrystalline Cellulose Filipendula Ulmaria Flower Cocoa Butter Safflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-26

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.
Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating
  • immediately after towel-drying
  • at least every 2 hours.

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 of 15 or higher and other protection measures including:

  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor.
Do Not Use

on damaged or broken skin

Active Ingredient

Zinc Oxide 20.0%

Other Information
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics and surfaces.
Product Packaging

Inactive Ingredients

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Seed Oil, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Theobroma Cacao (Cocoa) Seed Butter*, Bisabolol*, Tocopherol, Cetyl Alcohol, Caprylyl Glycol, Coco-Glucoside, Behenyl Alcohol, Arachidyl Glucoside, Arachidyl Alcohol, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Sodium Hyaluronate, Glycerin, Caprylhydroxamic Acid, Cellulose Gum..*Certified Organic Ingredients

Questions Or Comments?

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

When Using This Product

keep out of eyes. Rinse with water to remove

Stop Use and Ask Doctor If

rash occurs

Keep Out of Reach of Children.

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


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

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating
  • immediately after towel-drying
  • at least every 2 hours.

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 of 15 or higher and other protection measures including:

  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor.
Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Zinc Oxide 20.0%

Other Information (Other information)
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics and surfaces.
Product Packaging

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Seed Oil, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Theobroma Cacao (Cocoa) Seed Butter*, Bisabolol*, Tocopherol, Cetyl Alcohol, Caprylyl Glycol, Coco-Glucoside, Behenyl Alcohol, Arachidyl Glucoside, Arachidyl Alcohol, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Sodium Hyaluronate, Glycerin, Caprylhydroxamic Acid, Cellulose Gum..*Certified Organic Ingredients

Questions Or Comments? (Questions or comments?)

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove

Stop Use and Ask Doctor If (Stop use and ask 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 immediately.


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