Daily Spf Facial Sunscreen Lotion Broad Spectrum Spf 32

Daily Spf Facial Sunscreen Lotion Broad Spectrum Spf 32
SPL v4
SPL
SPL Set ID c11197f4-cee0-04b3-e053-2995a90a1ba8
Route
TOPICAL
Published
Effective Date 2025-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (210 mg)
Inactive Ingredients
Levomenol Caprylhydroxamic Acid Phytate Sodium Betasizofiran Sucrose Phaeodactylum Tricornutum Anhydrous Dextrose Spirulina Maxima Tocopherol C8-10 Alcohols Water Medium-chain Triglycerides Coconut Alkanes Cetostearyl Alcohol Glycerin Aloe Vera Leaf Argan Oil .alpha.-tocopherol Acetate Coco Glucoside Sunflower Oil Glyceryl Monocaprylate Shea Butter Cetearyl Glucoside Caprylyl/capryl Oligoglucoside Lecithin, Soybean Polyglyceryl-3 Ricinoleate Polyhydroxystearic Acid (2300 Mw) Coco-caprylate/caprate Xanthan Gum Starch, Rice Isostearic Acid Glycyrrhizinate Dipotassium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-03

Description

Active Ingredients: Zinc Oxide 21%


Medication Information

Warnings and Precautions

Warning: For external use only.

Indications and Usage

Uses:

  • Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.
Dosage and Administration

Directions:

Apply generously 15 minutes before sun exposer. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 

Sun protection measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

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

Active Ingredients: Zinc Oxide 21%

Section 50565-1

Keep out of reach of children: If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor: If rash occurs.

Section 50567-7

When using this products: Keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use: on damaged or broken skin.

Section 51727-6

Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Helianthus annuus (sunflower) seed oil, Coco-Glucoside, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Glucoside , Xanthan Gum, Coco-Caprylate/Caprate, Lecithin,  Caprylyl/Capryl Glucoside, Polyhydroxystearic Acid , Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Oryza Sativa Starch,  Dipotassium Glycyrrhizate, Bisabolol, Caprylhydroxamic Acid, Sodium Pthalate, Sclerotium Gum, Sucrose, Phaeodactylum Tricornutum Extract, Glucose, Spirulina Maxima Extract, Tocopherol, C10 Alochol, C8 Alcohol. 

Section 51945-4

Section 55105-1

Purpose:  Sunscreen

Section 55106-9

Active Ingredients:

Zinc Oxide 21%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.
Dosage and Administration (34068-7)

Directions:

Apply generously 15 minutes before sun exposer. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 

Sun protection measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.
Warnings and Precautions (34071-1)

Warning: For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children: If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor: If rash occurs.

Section 50567-7 (50567-7)

When using this products: Keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use: on damaged or broken skin.

Section 51727-6 (51727-6)

Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Helianthus annuus (sunflower) seed oil, Coco-Glucoside, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Glucoside , Xanthan Gum, Coco-Caprylate/Caprate, Lecithin,  Caprylyl/Capryl Glucoside, Polyhydroxystearic Acid , Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Oryza Sativa Starch,  Dipotassium Glycyrrhizate, Bisabolol, Caprylhydroxamic Acid, Sodium Pthalate, Sclerotium Gum, Sucrose, Phaeodactylum Tricornutum Extract, Glucose, Spirulina Maxima Extract, Tocopherol, C10 Alochol, C8 Alcohol. 

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:  Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Zinc Oxide 21%

Section 60561-8 (60561-8)

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


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Raw Label Data

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