Fre Glow Me Lightweight Tinted Moisturizer Spf 30 Light-medium

Fre Glow Me Lightweight Tinted Moisturizer Spf 30 Light-medium
SPL v3
SPL
SPL Set ID 6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a
Route
TOPICAL
Published
Effective Date 2023-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (19.2 g)
Inactive Ingredients
Water Coco-caprylate Glyceryl Monooleate Citrate Stearyl/octyldodecyl Citrate Crosspolymer Lauryl Glucoside Xanthan Gum Panthenol Propanediol Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane Isomalt Medium-chain Triglycerides Glycerin Myristyl Glucoside Caprylyl Glycol Phytate Sodium Lauroyl Lysine Argania Spinosa Leaf Caprylhydroxamic Acid Tocopherol Bergamot Oil East Indian Lemongrass Oil Lavender Oil Carnosine Argan Oil Lecithin, Soybean Titanium Dioxide Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-15

Description

Zinc Oxide 19.2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 19.2%

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.
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
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 including:

• limit time in the sun, especially from 10 am to 2 p.m.

• wear long-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months: ask a doctor

Drug Facts

Product Label

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 19.2%

Inactive Ingredients

Water (Aqua), Coco-Caprylate, Glyceryl Oleate Citrate, Stearyl Octyldodecyl Citrate Crosspolymer, Lauryl Glucoside, Xanthan Gum,Panthenol, Argania Spinosa Kernel Oil, Polyglyceryl-6 Laurate,Propanediol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Isomalt,Caprylic/Capric Triglyceride, Glycerin, Myristyl Glucoside, Caprylyl Glycol, Sodium Phytate, Lauroyl Lysine, Argania Spinosa Leaf Extract,Caprylhydroxamic Acid, Tocopherol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Cymbopogon, Flexuosus Oil, Lavandula Angustifolia (Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin, Titanium Dioxide, Iron Oxide Yellow (CI 77492), Iron Oxide Red (CI 77491), Iron Oxide Black (CI 77499).

Questions Or Comments

Call toll free 1-888-589-6243

Keep Out of Reach of Children.

If swallowed, call a Poison Control Center or get medical help 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.
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
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 including:

• limit time in the sun, especially from 10 am to 2 p.m.

• wear long-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months: ask a doctor

Drug Facts

Product Label (Product label)

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

Zinc Oxide 19.2%

Inactive Ingredients

Water (Aqua), Coco-Caprylate, Glyceryl Oleate Citrate, Stearyl Octyldodecyl Citrate Crosspolymer, Lauryl Glucoside, Xanthan Gum,Panthenol, Argania Spinosa Kernel Oil, Polyglyceryl-6 Laurate,Propanediol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Isomalt,Caprylic/Capric Triglyceride, Glycerin, Myristyl Glucoside, Caprylyl Glycol, Sodium Phytate, Lauroyl Lysine, Argania Spinosa Leaf Extract,Caprylhydroxamic Acid, Tocopherol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Cymbopogon, Flexuosus Oil, Lavandula Angustifolia (Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin, Titanium Dioxide, Iron Oxide Yellow (CI 77492), Iron Oxide Red (CI 77491), Iron Oxide Black (CI 77499).

Questions Or Comments (Questions or Comments)

Call toll free 1-888-589-6243

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call a Poison Control Center or get medical help right  away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)