Daily Dose Bioretinol + Mineral Spf 40

Daily Dose Bioretinol + Mineral Spf 40
SPL v2
SPL
SPL Set ID eb5bbc70-dbdf-06a8-e053-2995a90a66c1
Route
TOPICAL
Published
Effective Date 2022-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (16.5 g)
Inactive Ingredients
Quercus Robur Twig Bark Dicaprylyl Ether Butyloctyl Salicylate Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Sodium Chloride Tocopherol Camellia Sinensis Flower Propylene Carbonate Quercus Robur Wood Water Medium-chain Triglycerides Silicon Dioxide Olive Oil Polyglyceryl-6 Esters Polyhydroxystearic Acid (2300 Mw) Isohexadecane Glycerin Polyglyceryl-6 Dioleate Peg-6 Sorbitan Oleate Vinylpyrrolidone/hexadecene Copolymer Ethylhexylglycerin Vitis Vinifera Seed Trisodium Ethylenediamine Disuccinate Propanediol Bakuchiol Isododecane Disteardimonium Hectorite Carnosine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-18

Description

Zinc Oxide 16.5% Sunscreen


Medication Information

Warnings and Precautions

For External use only

Do not use on damaged or broken skin

When using this product, Keep our of eyes. Rinse with water to remove

Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and Administration

Directions

• apply generously and evenly 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ◦ Limit time in the sun, especially from 10 a.m. - 2 p.m. ◦ Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor

Description

Zinc Oxide 16.5% Sunscreen

Section 50565-1

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

Section 51727-6

Inactive Ingredients:

Aqua/Water/Eau, Dicaprylyl Ether, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Silica, Olive Oil Polyglyceryl-6 Esters, Isohexadecane, Glycerin, Sorbitan Oleate, VP/Hexadecene Copolymer, Polyhydroxystearic acid, Polyglyceryl-6 Pentaoleate, Propanediol, Bakuchiol, Ethylhexylglycerin, Isododecane, Sodium Chloride, Tocopherol, Disteardimonium Hectorite, Camellia Sinensis Leaf Extract, Propylene Carbonate, Quercus Robur Bark Extract, Quercus Robur Wood Extract, Vitis Vinifera (Grape) Seed Extract, Carnosine, Trisodium Ethylenediamine Disuccinate

Section 51945-4

Daily Dose Bioretinol + Mineral SPF

SPF 40

Broad Spectrum Sunscreen Fluid

1 fl. oz. / 30 mL

Section 55105-1

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

Section 55106-9

Zinc Oxide 16.5% 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 generously and evenly 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ◦ Limit time in the sun, especially from 10 a.m. - 2 p.m. ◦ Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

For External use only

Do not use on damaged or broken skin

When using this product, Keep our of eyes. Rinse with water to remove

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients:

Aqua/Water/Eau, Dicaprylyl Ether, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Silica, Olive Oil Polyglyceryl-6 Esters, Isohexadecane, Glycerin, Sorbitan Oleate, VP/Hexadecene Copolymer, Polyhydroxystearic acid, Polyglyceryl-6 Pentaoleate, Propanediol, Bakuchiol, Ethylhexylglycerin, Isododecane, Sodium Chloride, Tocopherol, Disteardimonium Hectorite, Camellia Sinensis Leaf Extract, Propylene Carbonate, Quercus Robur Bark Extract, Quercus Robur Wood Extract, Vitis Vinifera (Grape) Seed Extract, Carnosine, Trisodium Ethylenediamine Disuccinate

Section 51945-4 (51945-4)

Daily Dose Bioretinol + Mineral SPF

SPF 40

Broad Spectrum Sunscreen Fluid

1 fl. oz. / 30 mL

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Zinc Oxide 16.5% Sunscreen


Advanced Ingredient Data


Raw Label Data

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