derma: b everyday aqua fit sunscreen spf 50

derma: b everyday aqua fit sunscreen spf 50
SPL v2
SPL
SPL Set ID ba38a43d-7a8a-4814-ba34-0e99124f5fca
Route
topical
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (95 mg) ethylhexyl salicylate (45 mg) octocrylene (60 mg)
Inactive Ingredients
hyaluronic acid hyaluronate sodium myristoyl/palmitoyl oxostearamide/arachamide mea water dipropylene glycol butyloctyl salicylate silicon dioxide cetostearyl alcohol glyceryl monostearate cetearyl olivate polysorbate 60 caprylyl glycol sorbitan olivate polyacrylate-13 dimethicone sorbitan stearate peg-100 monostearate ethylhexylglycerin 1,2-hexanediol ethylhexyl methoxycrylene .alpha.-tocopherol acetate panthenol xanthan gum butylene glycol edetate disodium pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) propanediol polysorbate 20 sorbitan isostearate pentylene glycol madecassoside decyl glucoside

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-15

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 9.5 Octisalate 4.5% Octocrylene 6%


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

• 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 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

Water (Aqua), Dipropylene Glycol, Butyloctyl Salicylate, Silica, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Polysorbate 60, Caprylyl Glycol, Sorbitan Olivate, Polyacrylate-13, Dimethicone, Sorbitan Stearate, Peg-100 Stearate, Fragrance (Parfum), Polyisobutene, Ethylhexylglycerin, 1,2-Hexanediol, Ethylhexyl Methoxycrylene, Tocopheryl Acetate, Panthenol, Xanthan Gum, Butylene Glycol, Disodium EDTA, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Propanediol, Polysorbate 20, Sorbitan Isostearate, Pentylene Glycol, Madecassoside, Decyl Glucoside, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA

Description

Avobenzone 3% Homosalate 9.5 Octisalate 4.5% Octocrylene 6%

Do Not Use
  • on damaged or broken skin
Drug Facts

Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 9.5

Octisalate 4.5%

Octocrylene 6%

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 Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

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

• 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 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)

Water (Aqua), Dipropylene Glycol, Butyloctyl Salicylate, Silica, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Polysorbate 60, Caprylyl Glycol, Sorbitan Olivate, Polyacrylate-13, Dimethicone, Sorbitan Stearate, Peg-100 Stearate, Fragrance (Parfum), Polyisobutene, Ethylhexylglycerin, 1,2-Hexanediol, Ethylhexyl Methoxycrylene, Tocopheryl Acetate, Panthenol, Xanthan Gum, Butylene Glycol, Disodium EDTA, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Propanediol, Polysorbate 20, Sorbitan Isostearate, Pentylene Glycol, Madecassoside, Decyl Glucoside, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA

Do Not Use (Do not use)
  • on damaged or broken skin
Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 9.5

Octisalate 4.5%

Octocrylene 6%

When Using This product (When using this product)
  • keep out of eyes. Rinse with water to remove.
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.

Advanced Ingredient Data


Raw Label Data

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