drug facts:

Drug Facts

Composition & Product

Active Ingredients

titanium dioxide (80 mg) zinc oxide (38 mg)

Inactive Ingredients

aluminum hydroxide cyclomethicone 6 cyclomethicone 5 dimethicone 20 dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) dimethicone/vinyl dimethicone crosspolymer (soft particle) dimethiconol (2000 cst) brown iron oxide lauryl peg/ppg-18/18 methicone hydrogen dimethicone (20 cst) peg-10 dimethicone (600 cst) tetrahexyldecyl ascorbate .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2022-01-22

Medication Information

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

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 42229-5

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 10:00 am - 2:00 pm
Wear long-sleeved shirts, pants, hats, and sunglasses

Section 50565-1

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

Purpose:

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove.

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Children under 6 months: Ask a doctor

Other Information:

Protect this product from excessive heat and direct sun
May stain some fabrics
PA +++

Manufactured by Emme Diane™

Scottsdale, AZ - www.emmediane.com

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (Cl 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel – 53 G Bottle Label

EMME DIANE

TINTED

MINERAL

SUNSCREEN

BROAD SPECTRUM SPF 40

WATER RESISTANT

(80 MINUTES)

NET WT. 1.8 OZ (53 G)

Structured Label Content

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 42229-5 (42229-5)

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 10:00 am - 2:00 pm
Wear long-sleeved shirts, pants, hats, and sunglasses

Section 50565-1 (50565-1)

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

Purpose:

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove.

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Children under 6 months: Ask a doctor

Other Information:

Protect this product from excessive heat and direct sun
May stain some fabrics
PA +++

Manufactured by Emme Diane™

Scottsdale, AZ - www.emmediane.com

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (Cl 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel – 53 G Bottle Label (Principal Display Panel – 53 g Bottle Label)

EMME DIANE

TINTED

MINERAL

SUNSCREEN

BROAD SPECTRUM SPF 40

WATER RESISTANT

(80 MINUTES)

NET WT. 1.8 OZ (53 G)

Advanced Ingredient Data

[{"name": "Titanium Dioxide", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Zinc Oxide", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "38", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Aluminum Hydroxide", "unii": "5QB0T2IUN0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Cyclomethicone 6", "unii": "XHK3U310BA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Cyclomethicone 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dimethicone 20", "unii": "H8YMB5QY0D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane)", "unii": "UF7620L1W6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)", "unii": "9E4CO0W6C5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dimethiconol (2000 CST)", "unii": "T74O12AN6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Brown Iron Oxide", "unii": "1N032N7MFO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Lauryl PEG/PPG-18/18 Methicone", "unii": "ZJ5S27D9NX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrogen Dimethicone (20 CST)", "unii": "12Z59IF64N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-10 Dimethicone (600 CST)", "unii": "8PR7V1SVM0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Tetrahexyldecyl Ascorbate", "unii": "9LBV3F07AZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".Alpha.-Tocopherol Acetate", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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'", "42229-5": "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 10:00 am - 2:00 pm Wear long-sleeved shirts, pants, hats, and sunglasses", "50565-1": "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose:": "Sunscreen Sunscreen", "Warnings:": "For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove.", "Directions:": "Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor", "Other Information:": "Protect this product from excessive heat and direct sun May stain some fabrics PA +++ Manufactured by Emme Diane™ Scottsdale, AZ - www.emmediane.com", "Active Ingredients:": "Titanium Dioxide 8% Zinc Oxide 3.8%", "Inactive Ingredients:": "Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (Cl 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate", "Principal Display Panel – 53 g Bottle Label": "EMME DIANE TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 WATER RESISTANT (80 MINUTES) NET WT. 1.8 OZ (53 G)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information