SPL v7
SPL
SPL Set ID 39a5a3be-f9a7-4fa1-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2014-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Octocrylene (10 g) Oxybenzone (6 g) Avobenzone (3 g) Homosalate
Inactive Ingredients
Alcohol Aloe Vera Leaf Isobutane Caprylyl Glycol Alpha-tocopherol Acetate Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-15

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Uses
  • Helps prevent Sunburn
  • If used as directed with other sun protection measures (see Directions ), decreases the risk of cancer and early skin aging caused by the sun
Warnings

For external use only

Flammable. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120ºF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics

Directions

• Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face. • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: •after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Children under 6 months: Ask a doctor • 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.

Do Not Use

on damaged or broken skin

Other Information

Protect this product from excessive heat and direct sun

Acitve Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Inactive Ingredients

Alcohol Denat., Isobutane, Acrylates/Octylacrylamide Copolymer, Fragrance, Caprylyl Glycol, Tocopheryl Acetate, Mineral Oil, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

Call 1-800-SAFESUN, Mon-Fri

Principal Display Panel

BANANA

BOAT®

KiDS

MAX PROTECT & PLAY™

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 100

100

PROTECTS

FROM 99%

OF BURNING RAYS

PEDIATRICIAN TESTED

High Endurance vs. Water

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

When Using This Product

Keep away from face to avoid breathing it.

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 cancer and early skin aging caused by the sun
Purpose

Sunscreen

Warnings

For external use only

Flammable. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120ºF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics

Directions

• Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face. • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: •after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Children under 6 months: Ask a doctor • 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.

Do Not Use (Do not use)

on damaged or broken skin

Other Information

Protect this product from excessive heat and direct sun

Acitve Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

Inactive Ingredients

Alcohol Denat., Isobutane, Acrylates/Octylacrylamide Copolymer, Fragrance, Caprylyl Glycol, Tocopheryl Acetate, Mineral Oil, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or Comments?)

Call 1-800-SAFESUN, Mon-Fri

Principal Display Panel

BANANA

BOAT®

KiDS

MAX PROTECT & PLAY™

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 100

100

PROTECTS

FROM 99%

OF BURNING RAYS

PEDIATRICIAN TESTED

High Endurance vs. Water

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

When Using This Product (When using this product)

Keep away from face to avoid breathing it.

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.


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Raw Label Data

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