Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 4a89873c-7339-428d-8b67-7b96ef5c5b1b
Route
TOPICAL
Published
Effective Date 2016-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (15 g) Octisalate (5 g) Octocrylene (2.8 g) Oxybenzone (6 g)
Inactive Ingredients
Water Butyloctyl Salicylate Silicon Dioxide Glyceryl Monostearate Peg-100 Stearate Caprylyl Trisiloxane Benzyl Alcohol Ethylhexyl Stearate Yellow Wax Dimethicone Chlorphenesin Xanthan Gum Trideceth-6 Edetate Disodium Butylated Hydroxytoluene Glycyrrhizinate Dipotassium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-25

Description

AVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.8%, OXYBENZONE 6.0%

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Purpose

Sunscreen

Description

AVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.8%, 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

Section 55106-9

AVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.8%,

OXYBENZONE 6.0%

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
  • wear long-sleeve 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 this product from excessive heat and direct sun

Inactive Ingredients

Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Silica, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Methicone, Sodium Polyacrylate, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Ethylhexyl Stearate, Beeswax, Dimethicone, Chlorphenesin, Cetyl Dimethicone, Xanthan Gum, Trimethylsiloxysilicate, Fragrance, Trideceth-6, Disodium EDTA, BHT, Dipotassium Glycyrrhizate.

Principal Display Panel



62296-8900-4



SUNCARE



BROAD SPECTRUM



SPF 70



WATER RESISTANT

(80 MINUTES)

LIGHT WEIGHT

SUNSCREEN LOTION



SHEER

ULTA

5 fl oz/147 ml















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 the Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.

  • May stain some fabrics


Structured Label Content

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 and Precautions (34071-1)

For external use only

Section 55106-9 (55106-9)

AVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.8%,

OXYBENZONE 6.0%

Purpose

Sunscreen

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
  • wear long-sleeve 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 this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Silica, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Methicone, Sodium Polyacrylate, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Ethylhexyl Stearate, Beeswax, Dimethicone, Chlorphenesin, Cetyl Dimethicone, Xanthan Gum, Trimethylsiloxysilicate, Fragrance, Trideceth-6, Disodium EDTA, BHT, Dipotassium Glycyrrhizate.

Principal Display Panel



62296-8900-4



SUNCARE



BROAD SPECTRUM



SPF 70



WATER RESISTANT

(80 MINUTES)

LIGHT WEIGHT

SUNSCREEN LOTION



SHEER

ULTA

5 fl oz/147 ml















When Using This Product (When using this product)

keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of the Reach of Children (Keep out of the reach of children)

If product is swallowed, get medical help or contact a Poison Control Center right away.

  • May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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