sabal mineral sunscreen broad sprectrum spf-30

sabal mineral sunscreen broad sprectrum spf-30
SPL v2
SPL
SPL Set ID f917b446-4e10-4231-826e-fdac32e11186
Route
topical
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (140 mg)
Inactive Ingredients
aloe vera leaf water butyloctyl salicylate shea butter calendula officinalis flower green tea leaf medium-chain triglycerides caprylyl glycol chamomile citric acid monohydrate coconut oil decyl glucoside ethyl vanillin glycerin glyceryl laurate glyceryl monostearate helianthus annuus flowering top hydrogenated methyl abietate hydroxyethyl cellulose, unspecified lavender oil punica granatum root bark stearic acid xanthan gum corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-11

Purpose

Sunscreen

Description

Zinc Oxide 14%


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 14%

Questions?

Email: [email protected]

Call:(727)-209-7730

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.
Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying.

Sun Protection Measures:  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long sleeve shirts, pants, hats, and sunglasses.
Active Ingredient

Zinc Oxide 14%

Package Labeling:

Other Information:

Protect the product in this container from excessive heat and direct sunlight.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Chamomilla Recutita (Chamomile) Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Ethyl Vanillin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydrogenated Methyl Abietate, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Spirea Ulmaria (Meadowsweet) Extract, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Stop Use and Ask Doctor
  • if rash or irritation develops and lasts.
When Using This Product
  • keep out of eyes. Rinse with water to remove.
If Pregnant Or Breastfeeding,

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

Purpose

Sunscreen

Questions?

Email: [email protected]

Call:(727)-209-7730

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 (Do not use)
  • on damaged or broken skin.
Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying.

Sun Protection Measures:  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long sleeve shirts, pants, hats, and sunglasses.
Active Ingredient

Zinc Oxide 14%

Package Labeling:

Other Information:

Protect the product in this container from excessive heat and direct sunlight.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Chamomilla Recutita (Chamomile) Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Ethyl Vanillin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydrogenated Methyl Abietate, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Spirea Ulmaria (Meadowsweet) Extract, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Stop Use and Ask Doctor (Stop use and ask doctor)
  • if rash or irritation develops and lasts.
When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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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