155b1389-95e0-4056-94ed-e6eeefcfa4f2

SPL v1
SPL
SPL Set ID 155b1389-95e0-4056-94ed-e6eeefcfa4f2
Route
topical
Published
Effective Date 2015-02-03
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 2015-01-01

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
  • shake well and 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

Alcohol Denat., Isobutane, Polyester-8, Butane, Acrylates/Octylacrylamide Copolymer, Ethoxydiglycol, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Butylene Glycol, Fragrance (Parfum), Dimethicone, Trisiloxane, Polyester-10, Propylene Glycol Dibenzoate, Gardenia Tahitensis Flower, Tocopherol, Benzyl Alcohol, Butylphenyl Methylpropional, Citronellol, Coumarin, Limonene, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde.

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

Victoria's Secret Beauty Co., Dist

New York, NY 10019 U.S.A.

London, WC2E 9BA, UK

When Using This Product
  • keep out of eyes.  Rinse with water to remove.
  • 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)
  • shake well and 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)

Alcohol Denat., Isobutane, Polyester-8, Butane, Acrylates/Octylacrylamide Copolymer, Ethoxydiglycol, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Butylene Glycol, Fragrance (Parfum), Dimethicone, Trisiloxane, Polyester-10, Propylene Glycol Dibenzoate, Gardenia Tahitensis Flower, Tocopherol, Benzyl Alcohol, Butylphenyl Methylpropional, Citronellol, Coumarin, Limonene, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde.

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)

Victoria's Secret Beauty Co., Dist

New York, NY 10019 U.S.A.

London, WC2E 9BA, UK

When Using This Product (WHEN USING THIS PRODUCT)
  • keep out of eyes.  Rinse with water to remove.
  • 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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