Fre Glow Me + 50 Mineral Sunscreen Spf 50

Fre Glow Me + 50 Mineral Sunscreen Spf 50
SPL v2
SPL
SPL Set ID 1cf5b24a-e6fd-470a-e063-6294a90ab29c
Route
TOPICAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-01

Description

Active Ingredient: Zinc Oxide 24.0%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

Active Ingredient: 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.

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.

• If swallowed, get medical help

or contact a Poison Control Center right away.

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.

Drug Facts

Active Ingredient:

Zinc Oxide 24.0%

Other Information

Protect the product in this container from excessive heat and

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

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 Or 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.

• If swallowed, get medical help

or contact a Poison Control Center right away.

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.

Drug Facts

Active Ingredient:

Zinc Oxide 24.0%

Other Information (Other information)

Protect the product in this container from excessive heat and

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

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 Or Comments (Questions or Comments)



Call toll free 1-888-589-6243


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)