Blue Monarch Tinted Spf-50 (rose Gold)

Blue Monarch Tinted Spf-50 (rose Gold)
SPL v2
SPL
SPL Set ID 9ba00a03-1015-4946-8c9b-5ef377a32e4b
Route
TOPICAL
Published
Effective Date 2023-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (180 mg)
Inactive Ingredients
Aloe Vera Leaf Water Butyloctyl Salicylate Shea Butter Alkyl (c12-15) Benzoate C18-c21 Alkane Green Tea Leaf Medium-chain Triglycerides Caprylyl Glycol Citric Acid Monohydrate Watermelon Coconut Oil Decyl Glucoside Dodecane Glycerin Glyceryl Laurate Glyceryl Monostearate Ferric Oxide Red Mango Punica Granatum Root Bark Castor Oil Sorbitan Monostearate Stearic Acid .alpha.-tocopherol Acetate Blueberry Xanthan Gum Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-07

Description

Zinc Oxide 18.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18.00%

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • 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.
Drug Facts

Questions?

(617) 943-0951

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Zinc Oxide 18.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C18-21 Alkane, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Iron Oxides (Black, Red, Yellow), Mangifera lndica (Mango) Butter, Punica Granatum (Pomegranate) Extract, Ricinus Communis (Castor) Oil, Sorbitan Stearate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Vaccinium Angustifolium (Blueberry) Extract, Xanthan Gum, Zemea (Corn) Propanediol.

When Using This Product
  • keep out of eyes. Rinse with water to remove
Stop Use and Ask A Doctor If
  • rash or irritation developsand
If Pregnant Or Breast Feeding,

ask a health professional before use

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.
  • Higher SPF gives more sunburn protection
  • 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 (Do not use)
  • on damaged or broken skin.
Drug Facts

Questions?

(617) 943-0951

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Zinc Oxide 18.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C18-21 Alkane, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Iron Oxides (Black, Red, Yellow), Mangifera lndica (Mango) Butter, Punica Granatum (Pomegranate) Extract, Ricinus Communis (Castor) Oil, Sorbitan Stearate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Vaccinium Angustifolium (Blueberry) Extract, Xanthan Gum, Zemea (Corn) Propanediol.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation developsand
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

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.


Advanced Ingredient Data


Raw Label Data

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