Spf 50 Daily Uv Defense Broad Spectrum Sunscreen

Spf 50 Daily Uv Defense Broad Spectrum Sunscreen
SPL v3
SPL
SPL Set ID 2d814f8a-23b5-209f-e063-6394a90a5091
Route
TOPICAL
Published
Effective Date 2025-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10.8 g) Octinoxate (7.5 g)
Inactive Ingredients
Cyclopentasiloxane Benzyl Alcohol Xanthan Gum Pueraria Montana Var. Lobata Root Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Cetearyl Alcohol Matricaria Recutita Flowering Top Aloe Vera Leaf Peg-100 Stearate Glyceryl Stearate Ethylhexylglycerin Lemon Glycerin Polysorbate 60 Phenoxyethanol C12-15 Alkyl Benzoate Edetate Disodium Green Tea Leaf Octyldodecyl Neopentanoate Dimethicone Water Coconut Alkanes

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-06 Until 2025-08-15

Description

Active ingredients purpose Octinoxate 7.5% Sunscreen Zinc Oxide 10.8 Sunscreen


Medication Information

Warnings and Precautions

Warnings:

For external use only. Avoid contact with eyes. Rinse with water to remove. Do not use on damaged or broken skin.

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions: Apply liberally and evenly 15 minutes before sun exposure. Reapply as needed or after towel drying, swimming, or sweating.

Sun Protection Measures: Spending time in the sun increases 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

Reapply at least 2 hours. Use a water resistant sunscreen if swimming or sweating.

Children under 6 months, ask a doctor.

Description

Active ingredients purpose Octinoxate 7.5% Sunscreen Zinc Oxide 10.8 Sunscreen

Section 50565-1

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

Section 51727-6

Inactive ingredients: Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecanol Neopentanoate, Glycerin, Cetearyl Alcohol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Benzyl Alcohol, Dimeticone, Xanthan Gum, Phenoxyethanol, Ethylhexylgycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Limon (Lemon) Fruit Extract, Pueraria Lobata Root Extract

Section 51945-4

Vitality Institute

SPF 50 Daily UV Defense Broad Spectrum Sunscreen

2 Fl Oz / 59 mL

Section 55105-1

Uses: Helps prevent sunburn if used as directed with other sun protection ( see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 55106-9

Active ingredients purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 10.8 Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions: Apply liberally and evenly 15 minutes before sun exposure. Reapply as needed or after towel drying, swimming, or sweating.

Sun Protection Measures: Spending time in the sun increases 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

Reapply at least 2 hours. Use a water resistant sunscreen if swimming or sweating.

Children under 6 months, ask a doctor.

Warnings and Precautions (34071-1)

Warnings:

For external use only. Avoid contact with eyes. Rinse with water to remove. Do not use on damaged or broken skin.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients: Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecanol Neopentanoate, Glycerin, Cetearyl Alcohol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Benzyl Alcohol, Dimeticone, Xanthan Gum, Phenoxyethanol, Ethylhexylgycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Limon (Lemon) Fruit Extract, Pueraria Lobata Root Extract

Section 51945-4 (51945-4)

Vitality Institute

SPF 50 Daily UV Defense Broad Spectrum Sunscreen

2 Fl Oz / 59 mL

Section 55105-1 (55105-1)

Uses: Helps prevent sunburn if used as directed with other sun protection ( see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 55106-9 (55106-9)

Active ingredients purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 10.8 Sunscreen


Advanced Ingredient Data


Raw Label Data

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