Elixir Mineral Sunscreen Spray Spf-30

Elixir Mineral Sunscreen Spray Spf-30
SPL v2
SPL
SPL Set ID fa3c73a3-0dfb-4673-822a-45d946dee260
Route
TOPICAL
Published
Effective Date 2023-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (60 mg) Zinc Cation
Inactive Ingredients
Aloe Vera Leaf Water Green Tea Leaf Medium-chain Triglycerides Caprylyl/capryl Oligoglucoside Safflower Ethylhexylglycerin Glycerin Glyceryl Stearate Citrate Helianthus Annuus Flowering Top Phenoxyethanol Punica Granatum Root Bark Stearic Acid Tetrasodium Glutamate Diacetate Cocoa Tocopherol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-17

Description

Titanium Dioxide 6.00% Zinc Oxide 6.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 6.00% Zinc Oxide 6.00%

Uses:

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • 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 and as needed. • Children under 6 months of age: Ask a doctor. • 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.

















Reapply: Sun Protection Measures: 

Do Not Use:

On damaged or broken skin.

Active Ingredient

Titanium Dioxide 6.00% Zinc Oxide 6.00%

Other Information

• Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Other Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, *Carthamus Tinctorius (Safflower) Oil, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate Citrate, *Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum. 

*Denotes organic ingredients

When Using This Product:

• Keep out of eyes. • Rinse with water to remove.

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.

Stop Use and Consult Your Doctor

if a rash or irritation occurs.


Structured Label Content

Uses:

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • 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 and as needed. • Children under 6 months of age: Ask a doctor. • 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.

















Reapply: Sun Protection Measures: 

Do Not Use: (Do not use:)

On damaged or broken skin.

Active Ingredient

Titanium Dioxide 6.00% Zinc Oxide 6.00%

Other Information

• Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Other Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, *Carthamus Tinctorius (Safflower) Oil, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate Citrate, *Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum. 

*Denotes organic ingredients

When Using This Product: (When using this product:)

• Keep out of eyes. • Rinse with water to remove.

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.

Stop Use and Consult Your Doctor (Stop use and consult your doctor)

if a rash or irritation occurs.


Advanced Ingredient Data


Raw Label Data

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