Babo Botanicals Sensitive Baby Mineral Sunscreen Spf50

Babo Botanicals Sensitive Baby Mineral Sunscreen Spf50
SPL v1
SPL
SPL Set ID 088b81e4-76c7-6680-e063-6294a90acb73
Route
TOPICAL
Published
Effective Date 2020-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (197 mg)
Inactive Ingredients
Tamanu Oil Jojoba Oil Tocopherol Hydrogenated Jojoba Oil, Randomized Oryzanol White Wax Chamomile Levomenol Calendula Officinalis Flower Candelilla Wax Shea Butter Rice Bran Oil Octyldodecyl Oleate Filipendula Ulmaria Flower Cocoa Butter Calophyllum Tacamahaca Seed Oil Sunflower Oil Avocado Oil Nasturtium Officinale Flowering Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-25

Description

Zinc Oxide 19.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 19.7%

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

Package Labeling

Active Ingredient

Zinc Oxide 19.7%

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

Dist: by Babo Botanicals, Inc.

60 East 56th Street New York, NY 10022

Inactive Ingredients

Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Oleate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Butyrospermum Parkii (Shea) Butter*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Tocopherol.

*Certified Organic Ingredients

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

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

Package Labeling

Active Ingredient (Active ingredient)

Zinc Oxide 19.7%

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

Dist: by Babo Botanicals, Inc.

60 East 56th Street New York, NY 10022

Inactive Ingredients (Inactive ingredients)

Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Oleate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Butyrospermum Parkii (Shea) Butter*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Tocopherol.

*Certified Organic Ingredients

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (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

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