SPL v1
SPL
SPL Set ID 1fd0a790-c66c-216f-e063-6294a90ae971
Route
TOPICAL
Published
Effective Date 2024-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (8.8 g)
Inactive Ingredients
Water Green Tea Leaf Holy Basil Leaf Alaria Esculenta Olea Europaea Leaf Aloe Tricaprin Coco-glycerides Glycerin Cetostearyl Alcohol Cetyl Palmitate Polyhydroxystearic Acid Stearate Sorbitan Olivate Cetearyl Olivate Methylcellulose, Unspecified Coconut Oil Stearic Acid Luviset 360 Magnesium Aluminum Silicate Sorbitan Monopalmitate Tocopherol Xanthan Gum Aluminum Oxide Benzyl Alcohol Salicylic Acid Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Titanium Dioxide (non-nano) 8.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide (non-nano) 8.8%

Uses

■ Helps prevent sunburn.

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center right away.

Warnings

■ For external use only.

■ Do not use on damaged or broken skin.

■ Stop use and ask a doctor if rash occurs.

■ When using this product, keep out of eyes. Rinse with water to remove.

Directions

■ Apply liberally 15 minutes before sun exposure.

■ Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.

■ For children under 6 months of age; ask a doctor.

Drug Facts

Titanium Dioxide (non-nano) 8.8%

Other Info

Protect this product from excessive heat and sunlight.

Inactive Ingredients

Acrylates Copolymer, Alaria Esculenta (Wakame Seaweed) Extract*, Aloe Barbadensis (Aloe) Leaf Juice*, Alumina, Benzyl Alcohol, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cocoglycerides, Cocos Nucifera (Coconut Oil)*, Deionized Water, glycerin, Magnesium Aluminum Silicate, Methylcellulose, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Salicylic Acid, Sorbic Acid, Sorbitan Olivate, Sorbitan Palmitate, Stearic Acid, Tocopherol, Xanthan Gum.

*Certified Organic Ingredients

Package Label.principal Display Panel


Structured Label Content

Uses

■ Helps prevent sunburn.

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

Warnings

■ For external use only.

■ Do not use on damaged or broken skin.

■ Stop use and ask a doctor if rash occurs.

■ When using this product, keep out of eyes. Rinse with water to remove.

Directions (DIRECTIONS)

■ Apply liberally 15 minutes before sun exposure.

■ Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.

■ For children under 6 months of age; ask a doctor.

Drug Facts (DRUG FACTS)

Titanium Dioxide (non-nano) 8.8%

Other Info (OTHER INFO)

Protect this product from excessive heat and sunlight.

Inactive Ingredients (INACTIVE INGREDIENTS)

Acrylates Copolymer, Alaria Esculenta (Wakame Seaweed) Extract*, Aloe Barbadensis (Aloe) Leaf Juice*, Alumina, Benzyl Alcohol, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cocoglycerides, Cocos Nucifera (Coconut Oil)*, Deionized Water, glycerin, Magnesium Aluminum Silicate, Methylcellulose, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Salicylic Acid, Sorbic Acid, Sorbitan Olivate, Sorbitan Palmitate, Stearic Acid, Tocopherol, Xanthan Gum.

*Certified Organic Ingredients

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)