Fre Glow Me Spf 50 Lightweight Tinted Moisturizer Medium-deep

Fre Glow Me Spf 50 Lightweight Tinted Moisturizer Medium-deep
SPL v2
SPL
SPL Set ID 1d4559e7-91d4-6c85-e063-6394a90af895
Route
TOPICAL
Published
Effective Date 2024-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24 g)
Inactive Ingredients
East Indian Lemongrass Oil Lecithin, Soybean Ferric Oxide Yellow Ferric Oxide Red Argania Spinosa Leaf Caprylhydroxamic Acid Myristyl Glucoside Panthenol Coco-caprylate Stearyl/octyldodecyl Citrate Crosspolymer Tocopherol Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-6 Laurate Ferrosoferric Oxide Lavender Oil Lauryl Glucoside Argan Oil Glycerin Caprylyl Glycol Xanthan Gum Propanediol Medium-chain Triglycerides Phytate Sodium Carnosine Argania Spinosa Whole Lauroyl Lysine Water Triethoxycaprylylsilane Isomalt Glyceryl Monooleate Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15

Description

Zinc Oxide 24.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 24.0%

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.

Directions

• Shake well before use.

• Apply liberally 15 minutes before sun exposure.

• Reapply:

• After 40 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.

Do Not Use

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and

direct sun. Do not use if the seal is broken.

Active Ingredients

Zinc Oxide 24.0%

Inactive Ingredients

Water, Coco-Caprylate, Glyceryl Oleate Citrate,

Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Argania

Spinosa Kernel Oil, Polyhydroxystearic Acid, Panthenol,

Triethoxycaprylylsilane, Lauryl Glucoside, Polyglyceryl-6 Laurate,

Propanediol, Xanthan Gum, Myristyl Glucoside, Caprylic/Capric

Triglyceride, Isomalt, Glycerin, Caprylyl Glycol, Lauroyl Lysine,

Sodium Phytate, Argania Spinosa Leaf Extract, Caprylhydroxamic

Acid, Cymbopogon Flexuosus Oil, Lavandula Angustifolia

(Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract,

Lecithin, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron

Oxides (CI 77499).

Questions and Comments

Call toll free 1-888-589-6243

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 or contact a Poison Control Center right away.


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.

Directions

• Shake well before use.

• Apply liberally 15 minutes before sun exposure.

• Reapply:

• After 40 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.

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

Protect the product in this container from excessive heat and

direct sun. Do not use if the seal is broken.

Active Ingredients (Active ingredients)

Zinc Oxide 24.0%

Inactive Ingredients

Water, Coco-Caprylate, Glyceryl Oleate Citrate,

Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Argania

Spinosa Kernel Oil, Polyhydroxystearic Acid, Panthenol,

Triethoxycaprylylsilane, Lauryl Glucoside, Polyglyceryl-6 Laurate,

Propanediol, Xanthan Gum, Myristyl Glucoside, Caprylic/Capric

Triglyceride, Isomalt, Glycerin, Caprylyl Glycol, Lauroyl Lysine,

Sodium Phytate, Argania Spinosa Leaf Extract, Caprylhydroxamic

Acid, Cymbopogon Flexuosus Oil, Lavandula Angustifolia

(Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract,

Lecithin, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron

Oxides (CI 77499).

Questions and Comments

Call toll free 1-888-589-6243

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

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.


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Raw Label Data

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