Spf 30 Sunscreen

Spf 30 Sunscreen
SPL v1
SPL
SPL Set ID dc3f8339-23c1-4882-8682-685623027bdf
Route
TOPICAL
Published
Effective Date 2023-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octocrylene (50 mg) Octisalate
Inactive Ingredients
Water Glycerin Potassium Cetyl Phosphate Vinylpyrrolidone/hexadecene Copolymer Dimethicone Phenoxyethanol Caprylyl Glycol Levomenol Trolamine Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-20

Description

Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%

Uses:

Helps prevent sunburn.

Warnings:

Skin Cancer/Skin Aging Alert,Spending time in the sun increase your risk of skin cancer and early aging. This products has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only.

Do Not Use

on damaged or broken skin.

Directions:

Apply generously & evenly before sun exposure. Reapply as needed or after towel drying, swimming, or sweating.Ask doctor before using on children under 6 months.

Drug Questions: 

www.tekweld.com

Package Labeling:

Active Ingredients

Avobenzone 3%,

Homosalate 10%,

Octocrylene 10%,

Octisalate 5%

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Glycerin, Potassium Cetyl Phosphate, VP/Hexadecene Copolymer, Dimethicone, Phenoxyethanol, Acrylates/Beheneth-25, Methacrylate Copolymer, Caprylyl Glycol, Bisabolol, Fragrance, Triethanolamine, Disodium EDTA

When Using This Product

keep out of eyes, rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children,

if product is swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Uses:

Helps prevent sunburn.

Purpose

Sunscreen

Warnings:

Skin Cancer/Skin Aging Alert,Spending time in the sun increase your risk of skin cancer and early aging. This products has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only.

Do Not Use (Do not use)

on damaged or broken skin.

Directions:

Apply generously & evenly before sun exposure. Reapply as needed or after towel drying, swimming, or sweating.Ask doctor before using on children under 6 months.

Drug Questions: 

www.tekweld.com

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%,

Homosalate 10%,

Octocrylene 10%,

Octisalate 5%

Other Information: (Other information:)

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Glycerin, Potassium Cetyl Phosphate, VP/Hexadecene Copolymer, Dimethicone, Phenoxyethanol, Acrylates/Beheneth-25, Methacrylate Copolymer, Caprylyl Glycol, Bisabolol, Fragrance, Triethanolamine, Disodium EDTA

When Using This Product (When using this product)

keep out of eyes, rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children, (keep out of reach of children,)

if product is swallowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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