Coral Care Spf 30

Coral Care Spf 30
SPL v1
SPL
SPL Set ID 2749fa0e-aed5-6c9a-e063-6294a90a2bf1
Route
TOPICAL
Published
Effective Date 2024-12-06
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 Stearic Acid Cetearyl Alcohol Salicylic Acid Medium-chain Triglycerides Aloe Vera Leaf Magnesium Aluminum Silicate Xanthan Gum Alumina Cocoglycerides Glycerin Alaria Esculenta Sorbic Acid Sodium Chloride Cetearyl Olivate Cetyl Palmitate Polyhydroxystearic Acid (2300 Mw) Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Methylcellulose Holy Basil Leaf Sunflower Oil Benzyl Alcohol Sorbitan Olivate Olea Europaea Leaf Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-19

Description

Titanium Dioxide 8.8%


Medication Information

Warnings and Precautions

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.

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

Directions: apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at lease every 2 hours. For children under 6 months of age: ask a doctor.

Description

Titanium Dioxide 8.8%

Section 50565-1

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

Section 51727-6

Water/Aqua, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe)* Leaf Juice, Cocoglycerides, Glycerin, Camellia Sinensis (Green Tea)* Leaf Extract, Ocimum Tenuiflorum (Tulsi)* Extract, Alaria Esculenta (Wakame Seaweed)* Extract, Olea Europaea (Olive)* Leaf Extract, Sorbitan Olivate, Cetyl Palmitate, Cetearyl Olivate, Methylcellulose, Cetearyl Alcohol, Polyhydroxystearic Acid, Acrylates Copolymer, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Stearic Acid, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Maris Aqua (Sea Water).

*Organic Ingredients

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 8.8%


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

Directions: apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at lease every 2 hours. For children under 6 months of age: ask a doctor.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water/Aqua, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe)* Leaf Juice, Cocoglycerides, Glycerin, Camellia Sinensis (Green Tea)* Leaf Extract, Ocimum Tenuiflorum (Tulsi)* Extract, Alaria Esculenta (Wakame Seaweed)* Extract, Olea Europaea (Olive)* Leaf Extract, Sorbitan Olivate, Cetyl Palmitate, Cetearyl Olivate, Methylcellulose, Cetearyl Alcohol, Polyhydroxystearic Acid, Acrylates Copolymer, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Stearic Acid, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Maris Aqua (Sea Water).

*Organic Ingredients

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 8.8%


Advanced Ingredient Data


Raw Label Data

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