Tiger Baby: Baby Sunscreen Spf-50

Tiger Baby: Baby Sunscreen Spf-50
SPL v2
SPL
SPL Set ID f2aa0e03-e8b6-42d0-8fa0-2e96ca486b5c
Route
TOPICAL
Published
Effective Date 2022-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (200 mg)
Inactive Ingredients
Aloe Vera Leaf Water Butyloctyl Salicylate Shea Butter Green Tea Leaf Medium-chain Triglycerides Caprylyl/capryl Oligoglucoside Cetearyl Olivate Watermelon Coconut Oil Carrot Gluconolactone Glycerin Glyceryl Monostearate Helianthus Annuus Flowering Top Hyaluronic Acid Hydroxyethyl Cellulose, Unspecified Olive Oil Avocado Oil Sodium Benzoate Sorbitan Olivate Stearic Acid Tocopherol .alpha.-tocopherol Xanthan Gum Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-21

Description

Zinc Oxide 20.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20.00%

Uses:

• Helps prevent sunburn • Higher SPF gives more sunburn protection • 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:

External use only.

Do Not Use
  • on damaged or broken skin.
Directions:

• Apply liberally 15-minutes before sun exposure and as needed • Children under 6 months of age: ask a doctor. • Reapply: 

• After 80 minutes of swimming or sweating, 

• Immediately after towel drying.

• At least every 2 hours.

• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. Sun Protection Measures.

Active Ingredient

Zinc Oxide 20.00%

Package Labeling:5ml

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia  Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Cetearyl Olivate, Citrullus Lunatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Gluconolactone, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Hydroxyethylcellulose, Olea Europaea (Olive) Oil, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Sodium  Benzoate, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

Package Labeling:89ml

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If

rash or irritation develops and lasts.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 • Higher SPF gives more sunburn protection • 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:

External use only.

Do Not Use (Do not use)
  • on damaged or broken skin.
Directions:

• Apply liberally 15-minutes before sun exposure and as needed • Children under 6 months of age: ask a doctor. • Reapply: 

• After 80 minutes of swimming or sweating, 

• Immediately after towel drying.

• At least every 2 hours.

• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. Sun Protection Measures.

Active Ingredient

Zinc Oxide 20.00%

Package Labeling:5ml

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia  Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Cetearyl Olivate, Citrullus Lunatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Gluconolactone, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Hydroxyethylcellulose, Olea Europaea (Olive) Oil, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Sodium  Benzoate, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

Package Labeling:89ml

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 or irritation develops and lasts.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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)