SPL v5
SPL
SPL Set ID 616bd006-f69f-0a1a-e053-2991aa0a6616
Route
TOPICAL
Published
Effective Date 2018-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9 g) Avobenzone (2.7 g) Octocrylene (4.5 g) Octisalate
Inactive Ingredients
Polyethylene Glycol 400 Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate Cocoa Butter Dimethicone Silicon Dioxide Caprylyl Glycol Ethylhexyl Palmitate Medium-chain Triglycerides Diisobutyl Adipate Cetyl Alcohol Methyl Dihydroabietate Ceresin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-02

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 9.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 9.0%

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 51945-4

FREE FROM

Oxybenzone

Octinoxate

50+

WON'T

RUN INTO

EYES

BANANA

BOAT®

PEDIATRICIAN

TESTED

baby

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50+

No Added

Oils &

Fragrances

0.5 OZ.

(14.2 g)

BANANA

BOAT®

baby

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Water

Resistant

(80 Minutes)

0.5 OZ. (14.2g)

Warnings

For external use only.

May stain some fabrics.

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 sleeve 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

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 9.0%

Inactive Ingredients

Ozokerite, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Diisopropyl Adipate, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, PEG-8, Caprylyl Glycol, Silica, Lauryl PEG-8 Dimethicone, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer.

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

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 51945-4 (51945-4)

FREE FROM

Oxybenzone

Octinoxate

50+

WON'T

RUN INTO

EYES

BANANA

BOAT®

PEDIATRICIAN

TESTED

baby

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50+

No Added

Oils &

Fragrances

0.5 OZ.

(14.2 g)

BANANA

BOAT®

baby

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Water

Resistant

(80 Minutes)

0.5 OZ. (14.2g)

Purpose

Sunscreen

Warnings

For external use only.

May stain some fabrics.

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 sleeve 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

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 9.0%

Inactive Ingredients

Ozokerite, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Diisopropyl Adipate, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, PEG-8, Caprylyl Glycol, Silica, Lauryl PEG-8 Dimethicone, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer.

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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