SPL v1
SPL
SPL Set ID f9466f74-a626-48b5-8b83-88b0d163a29d
Route
TOPICAL
Published
Effective Date 2013-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.0 g) Octinoxate (7.5 g) Oxybenzone (6.0 g)
Inactive Ingredients
Water

Identifiers & Packaging

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

Description

Avobenzone 3.0%, Octinoxate 7.5%, Oxybenzone 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Octinoxate 7.5%, 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.

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.

Other Information

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

Product Packaging

Active Ingredients

Avobenzone 3.0%, Octinoxate 7.5%, Oxybenzone 6.0%

Company Information

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

Inactive Ingredients

Water (Aqua, Eau), C12-15 Alkyl Benzoate, Glycerin, Ethylhexyl Methoxycrylene, Fragrance (Parfum), Cocoglycerides, Dimethicone, Polyester-8, Diethylhexyl Syringylidenemalonate, VP/Eicosene Copolymer, Acrylates/Vinyl Neodecanoate Crosspolymer, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Gardenia Tahitensis Flower, Tocopherol, Tocopheryl Acetate, Ascorbyl Glucoside, Xanthan Gum, Cetyl Dimethicone, Glyceryl Stearate, Myristyl Myristate, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Chlorphenesin, Caprylic/Capric Triglyceride, Acrylates/Beheneth-25 Methacrylate Copolymer, Ethylhexylglycerin, Sodium Stearoyl Lactylate, Disodium EDTA, Sodium PCA, Sodium Hydroxide, Phenoxyethanol, Methylisothiazolinone.

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.

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%, Octinoxate 7.5%, 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)

Water (Aqua, Eau), C12-15 Alkyl Benzoate, Glycerin, Ethylhexyl Methoxycrylene, Fragrance (Parfum), Cocoglycerides, Dimethicone, Polyester-8, Diethylhexyl Syringylidenemalonate, VP/Eicosene Copolymer, Acrylates/Vinyl Neodecanoate Crosspolymer, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Gardenia Tahitensis Flower, Tocopherol, Tocopheryl Acetate, Ascorbyl Glucoside, Xanthan Gum, Cetyl Dimethicone, Glyceryl Stearate, Myristyl Myristate, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Chlorphenesin, Caprylic/Capric Triglyceride, Acrylates/Beheneth-25 Methacrylate Copolymer, Ethylhexylglycerin, Sodium Stearoyl Lactylate, Disodium EDTA, Sodium PCA, Sodium Hydroxide, Phenoxyethanol, Methylisothiazolinone.

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)