Fre Protect Body Ultra-light Gel Cream Spf 50

Fre Protect Body Ultra-light Gel Cream Spf 50
SPL v2
SPL
SPL Set ID 2cd83c55-851c-089e-e063-6294a90ad6bc
Route
TOPICAL
Published
Effective Date 2025-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24 g)
Inactive Ingredients
Water Coco-caprylate/caprate Dicaprylyl Ether Glycerin Propanediol Polyglyceryl-6 Stearate Silica Polyhydroxystearic Acid (2300 Mw) Grape Seed Oil Rosa Canina Fruit Niacinamide Shea Butter Jojoba Oil Triethoxycaprylylsilane Cetyl Alcohol Xanthan Gum Caprylyl Glycol Glyceryl Stearate Panthenol Argan Oil Ascorbyl Tetraisopalmitate Lecithin, Soybean Sclerotium Gum Pullulan Polyglyceryl-6 Behenate Caprylhydroxamic Acid Tocopherol Pongamia Pinnata Seed Pongamol Argania Spinosa Leaf Isomalt Ylang-ylang Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-14

Description

Zinc Oxide 24%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 24%

Uses

Helps prevent sunburn. • 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.

Section 51945-4

Warnings

• For external use only.

• Do not use on damaged or broken skin.

• When using this product, keep out of eyes.

Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If swallowed, get

medical help

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply:

• After 80 minutes of swimming or sweating.

• Immediately after towel drying.

• At least every 2 hours.

• Sun protection measures: Spending time in the

sun increases your risk of skin cancer and early skin

aging. To decrease this risk, regularly use a

sunscreen with a broad-spectrum SPF value of 15

or higher and other sun protection measures.

• Limit time in the sun, especially from 10 a.m.-2 p.m.

• Wear long-sleeved shirts, pants, hats, and

sunglasses.

• For children under 6 months of age: Ask a doctor.

Other Information

Protect this product in this container from

excessive heat and direct sun.

• Do not use if the seal is broken.

Active Ingredients

Zinc Oxide 24%

Inactive Ingredients



Water, Coco-Caprylate/Caprate, Dicaprylyl Ether,

Glycerin, Propanediol, Polyglyceryl-6 Stearate,

Silica, Polyhydroxystearic Acid, Vitis Vinifera (Grape)

Seed Oil, Rosa Canina Fruit Extract, Niacinamide,

Butyrospermum Parkii (Shea) Butter, Simmondsia

Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane,

Cetyl Alcohol, Xanthan Gum, Caprylyl Glycol,

Glyceryl Stearate, Argania Spinosa Kernel (Argan)

Oil, Panthenol, Ascorbyl Tetraisopalmitate, Lecithin,

Sclerotium Gum, Pullulan, Polyglyceryl-6 Behenate,

Caprylhydroxamic Acid, Tocopherol, Pongamia

Pinnata Seed Extract, Pongamol, Argania Spinosa

Leaf Extract, Argania Spinosa Callus Culture Extract,

Isomalt, Cananga Odorata Flower (Ylang-Ylang) Oil.

Questions & Comments?



Call toll free 1-888-589-6243


Structured Label Content

Uses

Helps prevent sunburn. • 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.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

• For external use only.

• Do not use on damaged or broken skin.

• When using this product, keep out of eyes.

Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If swallowed, get

medical help

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply:

• After 80 minutes of swimming or sweating.

• Immediately after towel drying.

• At least every 2 hours.

• Sun protection measures: Spending time in the

sun increases your risk of skin cancer and early skin

aging. To decrease this risk, regularly use a

sunscreen with a broad-spectrum SPF value of 15

or higher and other sun protection measures.

• Limit time in the sun, especially from 10 a.m.-2 p.m.

• Wear long-sleeved shirts, pants, hats, and

sunglasses.

• For children under 6 months of age: Ask a doctor.

Other Information (Other information)

Protect this product in this container from

excessive heat and direct sun.

• Do not use if the seal is broken.

Active Ingredients (Active ingredients)

Zinc Oxide 24%

Inactive Ingredients



Water, Coco-Caprylate/Caprate, Dicaprylyl Ether,

Glycerin, Propanediol, Polyglyceryl-6 Stearate,

Silica, Polyhydroxystearic Acid, Vitis Vinifera (Grape)

Seed Oil, Rosa Canina Fruit Extract, Niacinamide,

Butyrospermum Parkii (Shea) Butter, Simmondsia

Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane,

Cetyl Alcohol, Xanthan Gum, Caprylyl Glycol,

Glyceryl Stearate, Argania Spinosa Kernel (Argan)

Oil, Panthenol, Ascorbyl Tetraisopalmitate, Lecithin,

Sclerotium Gum, Pullulan, Polyglyceryl-6 Behenate,

Caprylhydroxamic Acid, Tocopherol, Pongamia

Pinnata Seed Extract, Pongamol, Argania Spinosa

Leaf Extract, Argania Spinosa Callus Culture Extract,

Isomalt, Cananga Odorata Flower (Ylang-Ylang) Oil.

Questions & Comments?



Call toll free 1-888-589-6243


Advanced Ingredient Data


Raw Label Data

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