dc7913d5-58f2-3077-e053-2a95a90a1627

SPL v3
SPL
SPL Set ID dc7913d5-58f2-3077-e053-2a95a90a1627
Route
topical
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Sunscreen

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.


Medication Information

Warnings

For external use only.

May stain some fabrics.

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

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
Other Information

Protect this product from excessive heat and direct sun

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.

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

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)

Do Not Use

on damaged or broken skin.

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

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

Warnings

For external use only.

May stain some fabrics.

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

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
Other Information (Other information)

Protect this product from excessive heat and direct sun

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.

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)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

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


Raw Label Data

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