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

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%

Purpose

Sunscreen


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

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

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

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)

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

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

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
Do Not Use (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 (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.

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

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)

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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Raw Label Data

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