1d8891aa-2e7f-41f8-a94e-d816809fd746

SPL v1
SPL
SPL Set ID 1d8891aa-2e7f-41f8-a94e-d816809fd746
Route
topical
Published
Effective Date 2013-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (1.8 g) octinoxate (7.5 g) octisalate (5.0 g) oxybenzone (2.4 g)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-08-28

Purpose

Sunscreen

Description

Avobenzone 1.8%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 2.4%


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, Isostearyl Neopentanoate, Cetearyl Alcohol, Myristyl Nicotinate, Glycerin, Cyclopentasiloxane, Hydrogenated Lecithin, Arctostaphylos Uva Ursi Leaf Extract, Betula Alba Bark Extract, Morus Alba Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cinnamomum Cassia Bark Extract, Glycine Soja (Soybean) Seed Extract, Rheum Palmatum Root/Stalk Extract, Sodium Hyaluronate, Arbutin, Dimethylcyclohexylethoxy Isobutylpropanoate, Phospholipids, Triacetin, N-Hydroxysuccinimide, Chrysin, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Dipotassium Glycyrrhizate, Trehalose, Xanthan Gum, Chlorphenesin, Isononyl Isononanoate, Pentaerythrityl Tetraethylhexanoate, Cetearyl Glucoside, Ascorbyl Glucoside, Tetrahexyldecyl Ascorbate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysilicone-11, Carbomer, Sucrose, Urea, Steareth-20, Sodium PCA, Cyclohexasiloxane, Polyquaternium-51, Disodium EDTA, Triethanolamine, Methyldihydrojasmonate, Cyclamen Aldehyde, Ethyl 2,2-Dimethylhydrocinnamal, Delphone, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Ethylparaben, Benzoic Acid, Isobutylparaben, Mica, Titanium Dioxide (CI 77891).

Description

Avobenzone 1.8%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 2.4%

Do Not Use

on damaged or broken skin.

Product Packaging

Active Ingredients

Avobenzone 1.8%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 2.4%

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, Isostearyl Neopentanoate, Cetearyl Alcohol, Myristyl Nicotinate, Glycerin, Cyclopentasiloxane, Hydrogenated Lecithin, Arctostaphylos Uva Ursi Leaf Extract, Betula Alba Bark Extract, Morus Alba Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cinnamomum Cassia Bark Extract, Glycine Soja (Soybean) Seed Extract, Rheum Palmatum Root/Stalk Extract, Sodium Hyaluronate, Arbutin, Dimethylcyclohexylethoxy Isobutylpropanoate, Phospholipids, Triacetin, N-Hydroxysuccinimide, Chrysin, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Dipotassium Glycyrrhizate, Trehalose, Xanthan Gum, Chlorphenesin, Isononyl Isononanoate, Pentaerythrityl Tetraethylhexanoate, Cetearyl Glucoside, Ascorbyl Glucoside, Tetrahexyldecyl Ascorbate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysilicone-11, Carbomer, Sucrose, Urea, Steareth-20, Sodium PCA, Cyclohexasiloxane, Polyquaternium-51, Disodium EDTA, Triethanolamine, Methyldihydrojasmonate, Cyclamen Aldehyde, Ethyl 2,2-Dimethylhydrocinnamal, Delphone, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Ethylparaben, Benzoic Acid, Isobutylparaben, Mica, Titanium Dioxide (CI 77891).

Do Not Use (DO NOT USE)

on damaged or broken skin.

Product Packaging (PRODUCT PACKAGING)

Active Ingredients (ACTIVE INGREDIENTS)

Avobenzone 1.8%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 2.4%

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

All Sections (JSON)