drug facts:

drug facts:
SPL v2
SPL
SPL Set ID b2b4daf5-765b-426d-8a72-9278f7cd43d7
Route
topical
Published
Effective Date 2023-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (160 mg)
Inactive Ingredients
medium-chain triglycerides ceramide np 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 hydrogen dimethicone (20 cst) peg-10 dimethicone (600 cst) polyhydroxystearic acid (2300 mw) tetrahexyldecyl ascorbate .alpha.-tocopherol acetate vinyl dimethicone/methicone silsesquioxane crosspolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-09-01
Purpose

Sunscreen

Description

Zinc Oxide 16%

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 16%

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 50565-1

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

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.

Section 50570-1

Do not use on damaged or broken skin.

Purpose:

Sunscreen

Warnings:

For external use only.

Directions:
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant product if swimming or sweating.
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor

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
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients:

Zinc Oxide 16%

Inactive Ingredients:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Principal Display Panel – 50 G Bottle Label

EMME DIANE

PURE

PROTECTION

TINTED ANTIOXIDANT

SUNSCREEN

SPF 40 BROAD SPECTRUM

NET WT. 1.75 OZ (50 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 50565-1 (50565-1)

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

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.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose:

Sunscreen

Warnings:

For external use only.

Directions:
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant product if swimming or sweating.
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor

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
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients:

Zinc Oxide 16%

Inactive Ingredients:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Principal Display Panel – 50 G Bottle Label (Principal Display Panel – 50 g Bottle Label)

EMME DIANE

PURE

PROTECTION

TINTED ANTIOXIDANT

SUNSCREEN

SPF 40 BROAD SPECTRUM

NET WT. 1.75 OZ (50 G)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.982221 · Updated: 2026-03-14T23:07:05.651363