SPL v1
SPL
SPL Set ID 33babd07-3bbb-4d22-8008-bcb47e3c9d94
Route
TOPICAL
Published
Effective Date 2013-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 mg) Homosalate (13.5 mg) Octinoxate (7.5 mg) Octisalate (4.6 mg) Octocrylene (2.4 mg) Oxybenzone (6.0 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-09-30

Description

Avobenzone 3.0%, Homosalate 13.5%, Octinoxate 7.5%, Octisalate 4.6%, Octocrylene 2.4%, Oxybenzone 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 13.5%, Octinoxate 7.5%, Octisalate 4.6%, Octocrylene 2.4%, Oxybenzone 6.0%

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
Warnings

For external use only.

Flammable

Keep away from flame or high heat.

  • Contents under pressure.  Do not puncture or incinerate.  Do not store at temperatures above 120°F (50°C).
Directions
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.  Hold container 4 to 6 inches from skin to apply.  Do not spray directly into face.  Spray on hands then apply to face.  Do not apply in windy conditions.  Use in a well ventilated area.
  • Reapply:
  • after 40 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 of age: ask a doctor
Do Not Use

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun.

Product Packaging

Active Ingredients

Avobenzone 3.0%, Homosalate 13.5%, Octinoxate 7.5%, Octisalate 4.6%, Octocrylene 2.4%, Oxybenzone 6.0%

Company Information

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

Inactive Ingredients

Isobutane, Alcohol Denat., Polyester-8, Acrylates/Octylacrylamide Copolymer, Cocos Nucifera (Coconut) Oil, Gardenia Tahitensis Flower, Tocopherol, Tocopheryl Acetate, Fragrance (Parfum), Dimethicone, Ethoxydiglycol, Butylene Glycol, Trisiloxane, Polyester-10, Propylene Glycol Dibenzoate.

When Using This Product
  • keep out of eyes.  Rinse with water to remove.
  • keep away from face to avoid breathing in
  • use only as directed.  Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Stop Use and Ask A Doctor If

rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses (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 (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only.

Flammable (FLAMMABLE)

Keep away from flame or high heat.

  • Contents under pressure.  Do not puncture or incinerate.  Do not store at temperatures above 120°F (50°C).
Directions (DIRECTIONS)
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.  Hold container 4 to 6 inches from skin to apply.  Do not spray directly into face.  Spray on hands then apply to face.  Do not apply in windy conditions.  Use in a well ventilated area.
  • Reapply:
  • after 40 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 of age: ask a doctor
Do Not Use (DO NOT USE)

on damaged or broken skin.

Other Information (OTHER INFORMATION)

Protect the product in this container from excessive heat and direct sun.

Product Packaging (PRODUCT PACKAGING)

Active Ingredients (ACTIVE INGREDIENTS)

Avobenzone 3.0%, Homosalate 13.5%, Octinoxate 7.5%, Octisalate 4.6%, Octocrylene 2.4%, Oxybenzone 6.0%

Company Information (COMPANY INFORMATION)

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

Inactive Ingredients (INACTIVE INGREDIENTS)

Isobutane, Alcohol Denat., Polyester-8, Acrylates/Octylacrylamide Copolymer, Cocos Nucifera (Coconut) Oil, Gardenia Tahitensis Flower, Tocopherol, Tocopheryl Acetate, Fragrance (Parfum), Dimethicone, Ethoxydiglycol, Butylene Glycol, Trisiloxane, Polyester-10, Propylene Glycol Dibenzoate.

When Using This Product (WHEN USING THIS PRODUCT)
  • keep out of eyes.  Rinse with water to remove.
  • keep away from face to avoid breathing in
  • use only as directed.  Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

rash occurs.

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

If swallowed, get medical help or contact a Poison Control Center immediately.


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Raw Label Data

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