Project Reef Mineral Sunscreen Spf-50

Project Reef Mineral Sunscreen Spf-50
SPL v2
SPL
SPL Set ID 87b9170c-956e-4aa2-9416-da00cca81b58
Route
TOPICAL
Published
Effective Date 2022-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (140 mg) Titanium Dioxide (60 mg)
Inactive Ingredients
Aloe Vera Leaf Water Benzyl Alcohol Shea Butter Green Tea Leaf Medium-chain Triglycerides Citric Acid Monohydrate Orange Oil, Cold Pressed Coconut Oil Decyl Glucoside Dehydroacetic Acid Ethyl Vanillin Fucus Vesiculosus Glycerin Glyceryl Monostearate Helianthus Annuus Flowering Top Hydroxyethyl Cellulose, Unspecified Lavender Oil Punica Granatum Root Bark Raspberry Stearic Acid Tridecyl Salicylate Xanthan Gum Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-21

Description

Zinc Oxide 14.00 %  Titanium Dioxide 6.00 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 14.00 %  Titanium Dioxide 6.00 %

Uses:

• Helps prevent sunburn. • higher SPF gives more sunburn protection • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

Warnings:

not intended for ingestion. For external use only

Do Not Use

• on damaged or broken skin.

Questions?

Call 800 914 0146

Directions:

• Apply liberally 15 minutes before sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours • Reapply as needed or after towel drying, swimming, or sweating. • Use a water-resistant sunscreen if swimming or sweating • 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.

Package Labeling:

Active Ingredients

Zinc Oxide 14.00 %  Titanium Dioxide 6.00 %

Other Information:

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

Inactive Ingredients:

Algae Extract, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, *Butyrospermum Parkii (Shea) Butter, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, *Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Ethyl Vanillin, Fucus Vesiculosus (Seaweed) Extract, *Glycerin, Glyceryl Stearate, Helianthus Annuus, *Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Rubus Idaeus (Raspberry) Extract, Stearic Acid, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol. *Denotes Organic Ingredient

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 ), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

Purpose

Sunscreen

Warnings:

not intended for ingestion. For external use only

Do Not Use (Do not use)

• on damaged or broken skin.

Questions?

Call 800 914 0146

Directions:

• Apply liberally 15 minutes before sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours • Reapply as needed or after towel drying, swimming, or sweating. • Use a water-resistant sunscreen if swimming or sweating • 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.

Package Labeling:

Active Ingredients

Zinc Oxide 14.00 %  Titanium Dioxide 6.00 %

Other Information:

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

Inactive Ingredients:

Algae Extract, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, *Butyrospermum Parkii (Shea) Butter, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, *Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Ethyl Vanillin, Fucus Vesiculosus (Seaweed) Extract, *Glycerin, Glyceryl Stearate, Helianthus Annuus, *Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Rubus Idaeus (Raspberry) Extract, Stearic Acid, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol. *Denotes Organic Ingredient

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

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