SPL v1
SPL
SPL Set ID 27714c63-4db2-4b2d-8f17-b2ef19687300
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) Octinoxate (7.5 mg) Octisalate (5.0 mg) Octocrylene (2.7 mg) Oxybenzone (4.0 mg)
Inactive Ingredients
Water

Identifiers & Packaging

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

Description

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 2.7%, Oxybenzone 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 2.7%, Oxybenzone 4.0%

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.

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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.

Active Ingredient

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 2.7%, Oxybenzone 4.0%

Other Information

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

Product Packaging

Company Information

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

Inactive Ingredients

Water (Aqua, Eau), Butylene Glycol, Neopentyl Glycol Diheptanoate, Polyester-8, Cetyl Alcohol, Glycerin, Myristyl Nicotinate, Behenyl Alcohol, Polyethylene, Potato Starch Modified, Polysilicone-11, Di-C12-15 Alkyl Fumarate, Polymethyl Methacrylate, Glyceryl Stearate, PEG-100 Stearate, Pyrus Malus (Apple) Fruit Extract, Cinnamomum Cassia Bark Extract, Glycine Soja (Soybean) Seed Extract, Rheum Palmatum Root/Stalk Extract, Yeast Extract (Faex), Bacopa Monniera Extract, Olea Europaea (Olive) Fruit Extract, Cupressus Sempervirens (Cypress) Oil, Caffeine, Fermented Sweet Black Tea, Palmitoyl Tetrapeptide-7, Pearl Powder, Soy Amino Acids, Hydrolyzed Soy Protein, Hydrolyzed Silk, Palmitoyl Oligopeptide, Phospholipids, Dimethicone, Tetrahexyldecyl Ascorbate, Humic Acids, Carbomer, Hydrogenated Lecithin, Ethylhexylglycerin, Caprylyl Glycol, Laureth-12, Hexylene Glycol, Teprenone, Dipropylene Glycol, Polysorbate 20, Isobutyl Methyl Tetrahydropyranol, Pentadecalactone, Methyl Salicylate, Silica, Disodium EDTA, Isopropyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Mica, Titanium Dioxide (CI 77891), Yellow 5 (CI 19140), Red 40 (CI 16035).

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 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.

Directions (DIRECTIONS)
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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.

Active Ingredient (ACTIVE INGREDIENT)

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 2.7%, Oxybenzone 4.0%

Other Information (OTHER INFORMATION)

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

Product Packaging (PRODUCT PACKAGING)

Company Information (COMPANY INFORMATION)

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua, Eau), Butylene Glycol, Neopentyl Glycol Diheptanoate, Polyester-8, Cetyl Alcohol, Glycerin, Myristyl Nicotinate, Behenyl Alcohol, Polyethylene, Potato Starch Modified, Polysilicone-11, Di-C12-15 Alkyl Fumarate, Polymethyl Methacrylate, Glyceryl Stearate, PEG-100 Stearate, Pyrus Malus (Apple) Fruit Extract, Cinnamomum Cassia Bark Extract, Glycine Soja (Soybean) Seed Extract, Rheum Palmatum Root/Stalk Extract, Yeast Extract (Faex), Bacopa Monniera Extract, Olea Europaea (Olive) Fruit Extract, Cupressus Sempervirens (Cypress) Oil, Caffeine, Fermented Sweet Black Tea, Palmitoyl Tetrapeptide-7, Pearl Powder, Soy Amino Acids, Hydrolyzed Soy Protein, Hydrolyzed Silk, Palmitoyl Oligopeptide, Phospholipids, Dimethicone, Tetrahexyldecyl Ascorbate, Humic Acids, Carbomer, Hydrogenated Lecithin, Ethylhexylglycerin, Caprylyl Glycol, Laureth-12, Hexylene Glycol, Teprenone, Dipropylene Glycol, Polysorbate 20, Isobutyl Methyl Tetrahydropyranol, Pentadecalactone, Methyl Salicylate, Silica, Disodium EDTA, Isopropyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Mica, Titanium Dioxide (CI 77891), Yellow 5 (CI 19140), Red 40 (CI 16035).

When Using This Product (WHEN USING THIS PRODUCT)

keep out of eyes.  Rinse with water to remove.

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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