33babd07-3bbb-4d22-8008-bcb47e3c9d94

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

Purpose

Sunscreen

Description

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


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
  • 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
Other Information

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

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.

Description

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

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).
Do Not Use

on damaged or broken skin.

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

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

Warnings (WARNINGS)

For external use only.

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

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
Other Information (OTHER INFORMATION)

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

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.

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).
Do Not Use (DO NOT USE)

on damaged or broken skin.

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

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.


Advanced Ingredient Data


Raw Label Data

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