Sunbetter Tone Smart Spf 68 Sunscreen Compact

Sunbetter Tone Smart Spf 68 Sunscreen Compact
SPL v5
SPL
SPL Set ID 8f119447-045b-43f3-e053-2995a90aea77
Route
TOPICAL
Published
Effective Date 2019-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (100 mg) Titanium Dioxide (84 mg)
Inactive Ingredients
Corn Oil Phenyl Trimethicone Hexyldecanol Cetylhydroxyproline Palmitamide Ethylhexylglycerin Himanthalia Elongata Phenylethyl Alcohol Octyldodecyl Neopentanoate Triethoxycaprylylsilane Water Ginger Medium-chain Triglycerides Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) .alpha.-bisabolol, (+/-)- Butyloctyl Salicylate Caprylyl Glycol Ceric Oxide Silicon Dioxide Sodium Chloride Stearic Acid Tribehenin Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer 1,2-hexanediol Disteardimonium Hectorite Poly(methyl Methacrylate; 450000 Mw) Apricot Kernel Oil .alpha.-tocopherol, Dl- Alpha-tocopherol Acetate Laureth-25 Laureth-3 Phenoxyethanol High Density Polyethylene Ceresin Dimethicone Methacrylate (3000 Mw) Aluminum Oxide Rapeseed Sterol Dimethicone Ferric Oxide Red Polyhydroxystearic Acid (2300 Mw) Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-03
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Dosage and Administration

Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

after 80 minutes of swimming or sweating.

immediately after towel drying.

at least every 2 hours.

use a water resistant sunscreen if swimming or sweating.

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 50565-1

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

Warnings
  • ​ For external use only.
  • 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.
Directions

  • 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 of age: Ask a doctor.
Drug Facts

Drug Facts

Other Information
  • Protect this product from excessive heat and direct sun.
Active Ingredients

Titanium Dioxide 8.4%

Zinc Oxide 10.0%

Inactive Ingredients

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Brassica Campestris (Rapeseed) Sterols, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetylhydroxyproline Palmitamide, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Hexyldecanol, Himanthalia Elongata Extract, Hydrogenated Vegetable Oil, Iron Oxides (CI 77491, CI 77492, CI 77499), Laureth-25, Laureth-3, Mica, Octyldodecyl Neopentanoate, Ozokerite, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyethylene, Polyhydroxystearic Acid, Polymethyl Methacrylate, Prunus Armeniaca (Apricot) Kernel Oil, Silica, Simethicone, Sodium Chloride, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Water, Zingiber Officinale (Ginger) Root Extract.

Questions Or Comments?

800-538-5600

Principal Display Panel

sun better™

Advanced Mineral Protection

BROAD SPECTRUM SPF 68

SUNSCREEN COMPACT

TONE SMART

Water-Resistant (80 Minutes)

Mineral Actives

skinbetter science ®

Net wt. 0.42 oz (12g)

Peel Here

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.
Dosage and Administration (34068-7)

Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

after 80 minutes of swimming or sweating.

immediately after towel drying.

at least every 2 hours.

use a water resistant sunscreen if swimming or sweating.

Section 50565-1 (50565-1)

Keep out of 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.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
Directions

  • 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 of age: Ask a doctor.
Drug Facts

Drug Facts

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Active Ingredients (Active ingredients)

Titanium Dioxide 8.4%

Zinc Oxide 10.0%

Inactive Ingredients (Inactive ingredients)

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Brassica Campestris (Rapeseed) Sterols, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetylhydroxyproline Palmitamide, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Hexyldecanol, Himanthalia Elongata Extract, Hydrogenated Vegetable Oil, Iron Oxides (CI 77491, CI 77492, CI 77499), Laureth-25, Laureth-3, Mica, Octyldodecyl Neopentanoate, Ozokerite, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyethylene, Polyhydroxystearic Acid, Polymethyl Methacrylate, Prunus Armeniaca (Apricot) Kernel Oil, Silica, Simethicone, Sodium Chloride, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Water, Zingiber Officinale (Ginger) Root Extract.

Questions Or Comments? (Questions or comments?)

800-538-5600

Principal Display Panel

sun better™

Advanced Mineral Protection

BROAD SPECTRUM SPF 68

SUNSCREEN COMPACT

TONE SMART

Water-Resistant (80 Minutes)

Mineral Actives

skinbetter science ®

Net wt. 0.42 oz (12g)

Peel Here

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:21.088159 · Updated: 2026-03-14T23:07:01.452935