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

Purpose

Sunscreen

Description

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


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

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

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
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.

Description

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

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















Do Not Use


on damaged or broken skin



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

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

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

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
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















Do Not Use (Do not use)


on damaged or broken skin



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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