27714c63-4db2-4b2d-8f17-b2ef19687300

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

Purpose

Sunscreen

Description

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


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
  • 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
Other Information

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

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).

Description

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

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%

Product Packaging

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.

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)
  • 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
Other Information (OTHER INFORMATION)

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

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).

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%

Product Packaging (PRODUCT PACKAGING)

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.

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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