Smooth Even Glow

Smooth Even Glow
SPL v5
SPL
SPL Set ID 3fa48151-fcb9-3d35-e063-6394a90a2eb6
Route
TOPICAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (7.5 g) Titanium Dioxide (3.2 g)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Mica Aluminum Hydroxide Water Buddleja Davidii Leaf Thymus Vulgaris Leaf Caprylic/capric Triglyceride Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) C13-15 Alkane Glycerin Octyldodecyl Neopentanoate Perfluoromethyldecalin Phenoxyethanol Caprylyl Glycol Sorbic Acid Sodium Chloride Sorbitan Monooleate Tetrasodium Edta C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Stearic Acid Cyclopentasiloxane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctorif rash occurs

Section 50567-7

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

Section 50570-1

Do not useon damaged or broken skin

Warnings

For external use only

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
  • 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 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor
Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Zinc Oxide 7.5%

Titanium Dioxide 3.2%

Inactive Ingredients

Water, Caprylic Capric Triglyceride, Cyclopentasiloxane, C30-45 Alkylcetearyl, Dimethicone Crosspolymer, C13-15 Alkane, Stearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Octyldodecyl Neopentanoate, Glycerin, Buddleja Davidii (Summer Lilac) Extract, Thymus Vulgaris (Thyme) Extract, Sodium Chloride, Sorbitan Oleate,Tetrasodium Edta, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Perflourodecalin, Mica, Titanium Dioxide (CI77891), Iron Oxides (CI77491).

Principal Display Panel 47 Gm

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)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctorif rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

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
  • 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 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor
Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Zinc Oxide 7.5%

Titanium Dioxide 3.2%

Inactive Ingredients

Water, Caprylic Capric Triglyceride, Cyclopentasiloxane, C30-45 Alkylcetearyl, Dimethicone Crosspolymer, C13-15 Alkane, Stearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Octyldodecyl Neopentanoate, Glycerin, Buddleja Davidii (Summer Lilac) Extract, Thymus Vulgaris (Thyme) Extract, Sodium Chloride, Sorbitan Oleate,Tetrasodium Edta, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Perflourodecalin, Mica, Titanium Dioxide (CI77891), Iron Oxides (CI77491).

Principal Display Panel 47 Gm (Principal Display Panel - 47 gm)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:07.750691 · Updated: 2026-03-14T23:10:21.394156