SPL v1
SPL
SPL Set ID cc8d7fcd-7526-4f54-a357-b84a7a3ae7be
Route
TOPICAL
Published
Effective Date 2016-04-11
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 2016-04-11

Description

Avobenzone 3.0%, Homosalate 13.5%, Octinoxate 7.5%, Octisalate 4.6%, Octocrylene 2.4%, Oxybenzone 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 13.5%, Octinoxate 7.5%, Octisalate 4.6%, Octocrylene 2.4%, 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.

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).
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
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%, 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

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.

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 right away.


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.

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).
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
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%, 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

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.

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 right away.


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