87283-003-01 Roe Wellness Spf 50 Mineral Powder

87283-003-01 Roe Wellness Spf 50 Mineral Powder
SPL v1
SPL
SPL Set ID 47dc8155-4abb-4bb7-e063-6294a90af1ad
Route
TOPICAL
Published
Effective Date 2026-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24.1 g) Titanium Dioxide (23.9 g)
Inactive Ingredients
Ci 77492 Ascorbic Acid Ci 77491 Mica Poly(methyl Methacrylate; 450000 Mw) .alpha.-tocopherol Camellia Sinensis Leaf Silica Ceramide 9 Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-08

Description

Titanium Dioxide 23.9% Zinc Oxide 24.1%


Medication Information

Warnings and Precautions

For external use only .

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

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

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

Indications and Usage

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor.

Dosage and Administration

Immediately after towel drying.

At least every 2 hours.

Description

Titanium Dioxide 23.9% Zinc Oxide 24.1%

Section 50565-1

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

Section 51727-6

Slica , Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491

Section 51945-4

Section 55105-1

Uses: Helps prevent sunburn.

Section 55106-9

Titanium Dioxide 23.9%

Zinc Oxide 24.1%


Structured Label Content

Indications and Usage (34067-9)

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor.

Dosage and Administration (34068-7)

Immediately after towel drying.

At least every 2 hours.

Warnings and Precautions (34071-1)

For external use only .

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

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

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

Section 50565-1 (50565-1)

Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

Section 51727-6 (51727-6)

Slica , Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses: Helps prevent sunburn.

Section 55106-9 (55106-9)

Titanium Dioxide 23.9%

Zinc Oxide 24.1%


Advanced Ingredient Data


Raw Label Data

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