441a46f0-ecda-4448-e054-00144ff88e88

SPL v9
SPL
SPL Set ID 441a46f0-ecda-4448-e054-00144ff88e88
Route
topical
Published
Effective Date 2017-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (4.5 g) zinc oxide (6.5 g)
Inactive Ingredients
isohexadecane sodium chloride dimethicone phenoxyethanol caprylyl glycol aluminum oxide sodium citrate water cetyl peg/ppg-10/1 dimethicone (hlb 2) ethylhexyl methoxycrylene glycerin methyl dihydroabietate aloe vera leaf butyloctyl salicylate .alpha.-tocopherol acetate, dl-

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2017-01-02 Until 2026-12-01

Purpose

Sunscreen

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%


Medication Information

Warnings

For external use only

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
  • 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 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, Methyl Dihydroabietate,Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%

Principal Display Panel

BANANA

BOAT

NEW

LOOK!

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPRECTRUM SPF 50+

50+

with

POWERSTAY

TECHNOLOGY

tear+sting free

High Endurance vs. Sweat & Water

Water Resistant

(80 Minutes)

1 FL.OZ. (29 mL)

BANANA

BOAT

NEW

LOOK!

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPRECTRUM SPF 50+

50+

with

POWERSTAY

TECHNOLOGY

tear+sting free

High Endurance vs. Sweat & Water

Water Resistant

(80 Minutes)

6 FL.OZ. (177 mL)

BONUS

25% MORE

7.5 oz vs 6 oz

BANANA

BOAT

NEW

LOOK!

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPRECTRUM SPF 50+

50+

with

POWERSTAY

TECHNOLOGY

tear+sting free

High Endurance vs. Sweat & Water

Water Resistant

(80 Minutes)

7.5 FL.OZ. (221.8 mL)

50%

MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT

NEW

LOOK!

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPRECTRUM SPF 50+

50+

with

POWERSTAY

TECHNOLOGY

tear+sting free

High Endurance vs. Sweat & Water

Water Resistant

(80 Minutes)

9 FL.OZ. (270 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.

May stain some fabrics.


Structured Label Content

Warnings

For external use only

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
  • 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 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 (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, Methyl Dihydroabietate,Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Principal Display Panel

BANANA

BOAT

NEW

LOOK!

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPRECTRUM SPF 50+

50+

with

POWERSTAY

TECHNOLOGY

tear+sting free

High Endurance vs. Sweat & Water

Water Resistant

(80 Minutes)

1 FL.OZ. (29 mL)

BANANA

BOAT

NEW

LOOK!

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPRECTRUM SPF 50+

50+

with

POWERSTAY

TECHNOLOGY

tear+sting free

High Endurance vs. Sweat & Water

Water Resistant

(80 Minutes)

6 FL.OZ. (177 mL)

BONUS

25% MORE

7.5 oz vs 6 oz

BANANA

BOAT

NEW

LOOK!

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPRECTRUM SPF 50+

50+

with

POWERSTAY

TECHNOLOGY

tear+sting free

High Endurance vs. Sweat & Water

Water Resistant

(80 Minutes)

7.5 FL.OZ. (221.8 mL)

50%

MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT

NEW

LOOK!

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPRECTRUM SPF 50+

50+

with

POWERSTAY

TECHNOLOGY

tear+sting free

High Endurance vs. Sweat & Water

Water Resistant

(80 Minutes)

9 FL.OZ. (270 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.

May stain some fabrics.


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