I Am Trying To List Sunscreen.

I Am Trying To List Sunscreen.
SPL v1
SPL
SPL Set ID cf1b4589-7450-5161-e053-2a95a90aabe0
Route
TOPICAL
Published
Effective Date 2022-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7 mg)
Inactive Ingredients
Coco-caprylate/caprate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-05-15

Description

Zinc oxide

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Zinc oxide

Use

helps prevent sunburn”

Section 50566-9

“Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Warnings

Do not use on damaged or broken skin”

“When using this product keep out of eyes. Rinse with water to remove.”

“Stop use and ask a doctor if rash occurs”

For sunscreen drug products that do not pass the Broad Spectrum Test or that have SPF values less than 15, the first statement under Warnings must be:

“Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Do Not Use

“Do not use on damaged or broken skin”

Other Information

“protect the product in this container from excessive heat and direct sun

Active Ingredient(s)

Zinc oxide

Inactive Ingredients

Water, Coco-Caprylate/Caprate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Jojoba Esters, Sylibum Marianum Ethyl Ether, Gum Arabica, Cetyl Palmitate, Sorbitan Palmitate, Sorbitan Olivate, Inulin, Tetrahexyldecyl Ascorbate, Crocus Chrysanthus Bulb Extract, Hedychium Coronarium Root Extract, Fructooligosaccharides, Punica Granatum Fruit Extract, Beta Vulgaris(beet) Root Extract, Ficus Carica (fig) Fruit Extract, Glyceryl Stearate, Tocopherol, Morus Alba Fruit Extracf, Ginkgo Biloba Nut Extract, Potassium Lactate, Lactic Acid, Triethoxycaprylylsilane, Polyhydroxystearate Acid, Sclerotium Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pullulan, Lecithin, Silica, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Glyceryl Caprylate, Nitrilotriacetic Acid Trisodium Salt, Propanediol, Polysorbate-60, Sorbitan Isostearate

Package Label Principal Display Panel

NDC: 82285-020-01

Please see the attached image

Sunscreen

Broadspectrum

SPF 30

UVA/UVB


Structured Label Content

Use

helps prevent sunburn”

Section 50566-9 (50566-9)

“Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Purpose

sunscreen

Warnings

Do not use on damaged or broken skin”

“When using this product keep out of eyes. Rinse with water to remove.”

“Stop use and ask a doctor if rash occurs”

For sunscreen drug products that do not pass the Broad Spectrum Test or that have SPF values less than 15, the first statement under Warnings must be:

“Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Do Not Use (Do not use)

“Do not use on damaged or broken skin”

Other Information (Other information)

“protect the product in this container from excessive heat and direct sun

Active Ingredient(s)

Zinc oxide

Inactive Ingredients (Inactive ingredients)

Water, Coco-Caprylate/Caprate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Jojoba Esters, Sylibum Marianum Ethyl Ether, Gum Arabica, Cetyl Palmitate, Sorbitan Palmitate, Sorbitan Olivate, Inulin, Tetrahexyldecyl Ascorbate, Crocus Chrysanthus Bulb Extract, Hedychium Coronarium Root Extract, Fructooligosaccharides, Punica Granatum Fruit Extract, Beta Vulgaris(beet) Root Extract, Ficus Carica (fig) Fruit Extract, Glyceryl Stearate, Tocopherol, Morus Alba Fruit Extracf, Ginkgo Biloba Nut Extract, Potassium Lactate, Lactic Acid, Triethoxycaprylylsilane, Polyhydroxystearate Acid, Sclerotium Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pullulan, Lecithin, Silica, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Glyceryl Caprylate, Nitrilotriacetic Acid Trisodium Salt, Propanediol, Polysorbate-60, Sorbitan Isostearate

Package Label Principal Display Panel (Package Label - Principal Display Panel)

NDC: 82285-020-01

Please see the attached image

Sunscreen

Broadspectrum

SPF 30

UVA/UVB


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)