DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (6.5 g) Titanium Dioxide (4.5 g)

Inactive Ingredients

Dimethicone Phenoxyethanol Alpha-tocopherol Acetate Ethylhexyl Methoxycrylene Sodium Chloride Water Aluminum Oxide Anhydrous Trisodium Citrate Medium-chain Triglycerides Isohexadecane Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Caprylyl Glycol Butyloctyl Salicylate Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2022-04-12 Until 2026-12-01

Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

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.

Warnings

For external use only.

May stain some fabrics.

Directions

Shake well

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 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

Do Not Use

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl

Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT

sensitive

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HYPOALLERGENIC

NO ADDED OILS & FRAGRANCES

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

When Using This Product

• Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

Purpose

Sunscreen

Warnings

For external use only.

May stain some fabrics.

Directions

Shake well

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 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

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

Protect this product from excessive heat and direct sun

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl

Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT

sensitive

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HYPOALLERGENIC

NO ADDED OILS & FRAGRANCES

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

When Using This Product (When using this product)

• Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children (Keep out of reach of children)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "6.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL METHOXYCRYLENE", "unii": "S3KFG6Q5X8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM OXIDE", "unii": "LMI26O6933", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS TRISODIUM CITRATE", "unii": "RS7A450LGA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOHEXADECANE", "unii": "918X1OUF1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)", "unii": "V2W71V8T0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLOCTYL SALICYLATE", "unii": "2EH13UN8D3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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.", "Purpose": "Sunscreen", "Warnings": "For external use only. May stain some fabrics.", "Directions": "Shake well 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 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", "Do not use": "on damaged or broken skin.", "Other information": "Protect this product from excessive heat and direct sun", "Active Ingredients": "Titanium Dioxide 4.5%, Zinc Oxide 6.5%.", "Inactive Ingredients": "Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate.", "Questions or comments?": "Call 1-800-SafeSun, Mon-Fri", "PRINCIPAL DISPLAY PANEL": "BANANA BOAT sensitive mineral 100% MINERAL BASED SUNSCREEN LOTION UVA/UVB BROAD SPECTRUM SPF 50+ 50+ HYPOALLERGENIC NO ADDED OILS & FRAGRANCES NO OXYBENZONE & PARABENS Water Resistant (80 Minutes) 6 FL. OZ. (177 mL)", "When using this product": "• Keep out of eyes. Rinse with water to remove", "Stop use and ask a doctor": "if rash occurs.", "Keep out of reach of children": "If product is swallowed, get medical help or contact a Poison Control Center right away."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information