8797 Babo Spf 50 Sheer Sunscreen Spray

8797 Babo Spf 50 Sheer Sunscreen Spray
SPL v8
SPL
SPL Set ID b441f976-4f2a-ba19-e053-2995a90ad79a
Route
TOPICAL
Published
Effective Date 2020-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g) Titanium Dioxide (4.65 g)
Inactive Ingredients
Water Butyloctyl Salicylate Carboxymethylcellulose Sodium, Unspecified Form Citric Acid Monohydrate Coco Glucoside Glycerin Heptyl Undecylenate Nasturtium Officinale Flowering Top Sodium Gluconate Caprylhydroxamic Acid Caprylyl Glycol Levomenol Silicon Dioxide Sodium Stearoyl Glutamate Aloe Vera Leaf Methyl Dihydroabietate Polyhydroxystearic Acid (2300 Mw) Filipendula Ulmaria Flower Aluminum Oxide Bentonite Calendula Officinalis Flower Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Chamomile Coconut Oil Cellulose, Microcrystalline Olive Oil Propanediol Cetostearyl Alcohol Sunflower Oil Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-01 Until 2024-06-30

Description

Titanium Dioxide 4.3% Zinc Oxide 14.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 4.3% Zinc Oxide 14.7%

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

• Shake well before use • Hold container 4 to 6 inches from the skin to apply • Apply liberally 15 minutes before sun exposure • Do not spray directly into face • Do not spray in windy condition • Use in well-ventilated area • 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

Other Information

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

Active Ingredients

Titanium Dioxide 4.3%



Zinc Oxide 14.7%

Inactive Ingredients

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Glycerin, Bisabolol*, Tocopherol (Vitamin E), Bentonite, Caprylyl Glycol, Coco-Glucoside, Citric Acid, Sodium Gluconate, Cellulose Gum, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Caprylhydroxamic Acid, Polyhydroxystearic Acid, Alumina, Silica.



*Certified Organic Ingredients

Questions and Comments?

Call 1-800-422-2987 Mon - Fri 9:00AM - 5:00PM EST

When Using This Product
  • keep out of eyes. Rinse with water to remove.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Stop Use and Ask Doctor If
  • rash occurs
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120° F.
Keep Out of Reach of Children.

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

Spf 50 Sheer Mineral Sensitive Spray Sunscreen


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

• Shake well before use • Hold container 4 to 6 inches from the skin to apply • Apply liberally 15 minutes before sun exposure • Do not spray directly into face • Do not spray in windy condition • Use in well-ventilated area • 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

Other Information

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

Active Ingredients (Active ingredients)

Titanium Dioxide 4.3%



Zinc Oxide 14.7%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Glycerin, Bisabolol*, Tocopherol (Vitamin E), Bentonite, Caprylyl Glycol, Coco-Glucoside, Citric Acid, Sodium Gluconate, Cellulose Gum, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Caprylhydroxamic Acid, Polyhydroxystearic Acid, Alumina, Silica.



*Certified Organic Ingredients

Questions and Comments? (Questions and comments?)

Call 1-800-422-2987 Mon - Fri 9:00AM - 5:00PM EST

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • rash occurs
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120° F.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Spf 50 Sheer Mineral Sensitive Spray Sunscreen (SPF 50 Sheer Mineral Sensitive Spray Sunscreen)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)