sphere 8- sunscreen 50 spf

sphere 8- sunscreen 50 spf
SPL v4
SPL
SPL Set ID 32be4eb3-f106-182d-e063-6394a90aa484
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4 g) zinc oxide (17.18 g) octocrylene (5 g)
Inactive Ingredients
ethyl ferulate tocopherol glycerin alkyl (c12-15) benzoate isostearic acid magnesium sulfate heptahydrate polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 mpa.s) soybean oil propylheptyl caprylate dimethicone isododecane water butylene glycol dicaprylate/dicaprate propanediol butyloctyl salicylate caprylic/capric triglyceride c15-19 alkane niacinamide 1,2-hexanediol panthenol propylene carbonate caprylyl glycol glyceryl caprylate dipropylene glycol aloe vera leaf juice cetyl diglyceryl tris(trimethylsiloxy)silylethyl dimethicone (3500 mm2/s) polyglyceryl-2 triisostearate silica disteardimonium hectorite triethoxycaprylylsilane dimethicone/peg-10/15 crosspolymer sodium citrate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-01
Purpose

Sunscreen

Description

Octisalate 4% Sunscreen Octocrylene 5% Sunscreen Zinc Oxide 17.18% Sunscreen

Medication Information

Warnings
  • When using this product keep out of eyes. Rinse with water to remove Stop use and ask doctor if rash or irritation occurs Do not use on damaged or broken skin or if allergic to any ingredient If swallowed, get medical help or contact a Poison Control Center
Purpose

Sunscreen

Directions
  • Shake well prior to use • Apply liberally to dry skin 15 minutes before sun exposure • For topical use only .Keep out of reach of children. For children under 6 months, ask doctor

  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the nsk, regularly use a suns een with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: Limit bane in sun, especially from 10am - 2pm

  • Wear long-sleeved stilts, pants, hats, and sunglasses, Reapply to dry skin at least every 2 hours. Use water resistant sunscreen if swimming or sweating.
Other Information

Protect from excessive heat.

Inactive Ingredients

Water(Aqua), Boyle* Glycol DicaorylateXicarxete, C12-15 Alkyl Benzoate, Propanedi01, Elutyloctyi Salicylat, CvryliciCapric Triglyteride, Glycerin, Lally PEG-10 Tris(Trimethylsilm) ilyiettyil Dimethiccne, C15-19 Mane, Niaciriamide, Polyglycenii-2 Triisosbearate, Magnesium Stitata-Heolatrydraie, Meleafied Soy can Oil GlycenflOctyklooecanol Polymer, Propylheptyl Caprylata, Silica, Dlabserdirnohlurn Hed01149, Dirnerlipme, Triethoxycaorytylsilane, 1,2-Hexanaciol, Pentlienol, Polyglycerk3 PolydlmeNsfoxyethyl Dinethicone, Propylene Carbonate, Aloe Berbadensis Leaf Juice, DirnethiconelPEG-1015 Crosspolymer, Cactityl Gycol, Glycerii Capritare, Ethyl Ferulate, Tocopherol, tsostearic Acid, Dipropylene Gird, Sodium Citrate

Description

Octisalate 4% Sunscreen Octocrylene 5% Sunscreen Zinc Oxide 17.18% Sunscreen

Use



Helps prevent sunburn and photo damage by UV/UVB exposure Higher SPF gives more sunburn protection. 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 50565-1

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 50567-7

Rinse with water to remove Stop use and ask doctor if rash or irritation occurs

Active Ingredient(s)

Octisalate 4% Sunscreen

Octocrylene 5% Sunscreen

Zinc Oxide 17.18% Sunscreen

Package Label Principal Display Panel

Structured Label Content

Warnings
  • When using this product keep out of eyes. Rinse with water to remove Stop use and ask doctor if rash or irritation occurs Do not use on damaged or broken skin or if allergic to any ingredient If swallowed, get medical help or contact a Poison Control Center
Purpose

Sunscreen

Directions
  • Shake well prior to use • Apply liberally to dry skin 15 minutes before sun exposure • For topical use only .Keep out of reach of children. For children under 6 months, ask doctor

  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the nsk, regularly use a suns een with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: Limit bane in sun, especially from 10am - 2pm

  • Wear long-sleeved stilts, pants, hats, and sunglasses, Reapply to dry skin at least every 2 hours. Use water resistant sunscreen if swimming or sweating.
Other Information (Other information)

Protect from excessive heat.

Inactive Ingredients (Inactive ingredients)

Water(Aqua), Boyle* Glycol DicaorylateXicarxete, C12-15 Alkyl Benzoate, Propanedi01, Elutyloctyi Salicylat, CvryliciCapric Triglyteride, Glycerin, Lally PEG-10 Tris(Trimethylsilm) ilyiettyil Dimethiccne, C15-19 Mane, Niaciriamide, Polyglycenii-2 Triisosbearate, Magnesium Stitata-Heolatrydraie, Meleafied Soy can Oil GlycenflOctyklooecanol Polymer, Propylheptyl Caprylata, Silica, Dlabserdirnohlurn Hed01149, Dirnerlipme, Triethoxycaorytylsilane, 1,2-Hexanaciol, Pentlienol, Polyglycerk3 PolydlmeNsfoxyethyl Dinethicone, Propylene Carbonate, Aloe Berbadensis Leaf Juice, DirnethiconelPEG-1015 Crosspolymer, Cactityl Gycol, Glycerii Capritare, Ethyl Ferulate, Tocopherol, tsostearic Acid, Dipropylene Gird, Sodium Citrate

Use



Helps prevent sunburn and photo damage by UV/UVB exposure Higher SPF gives more sunburn protection. 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 50565-1 (50565-1)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

Rinse with water to remove Stop use and ask doctor if rash or irritation occurs

Active Ingredient(s)

Octisalate 4% Sunscreen

Octocrylene 5% Sunscreen

Zinc Oxide 17.18% Sunscreen

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:02.285514 · Updated: 2026-03-14T23:08:30.723878