SPL v1
SPL
SPL Set ID 41027faa-7d61-4970-e063-6294a90a7df4
Route
TOPICAL
Published
Effective Date 2025-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.25 mg) Homosalate (0.021 mg) Octisalate (1.5 mg) Octocrylene (0.005 mg)
Inactive Ingredients
Hydrated Silica Sorbitan Isostearate Alpha-tocopherol Acetate T-butyl Alcohol Polysorbate 60 Pentylene Glycol Caprylhydroxamic Acid Ceteareth-20 Copernicia Cerifera (carnauba) Wax Peg-40 Stearate Ci 77492 Disodium Edta-copper Butylene Glycol Carnosine Titanium Dioxide Oryza Sativa (rice) Bran Water Glycerin Diisopropyl Adipate Kakadu Plum Citric Acid Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Alcohol Caprylyl Methicone Isododecane Dimethicone Nylon 612 (18000 Mw) Lactic Acid Ci 77491 Ci 77499 Triethanolamine Cetearyl Alcohol Mica Glyceryl Caprylate Squalane Saccharide Isomerate Fragrance 13576

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

AVOBENZONE 3.0% HOMOSALATE 7.0% OCTISALATE 5.0% OCTOCRYLENE 8.0%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

AVOBENZONE 3.0% HOMOSALATE 7.0% OCTISALATE 5.0% OCTOCRYLENE 8.0%

Use

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 44425-7

Other Information

Other information protect the product in this container from excessive heat and direct sun

Section 50567-7

Keep out of eyes. Rinse with water to remove.

Section 50570-1

For External Use Only

Section 51945-4

ULTRA

VIOLETTE

SEQUIN SUPREME SPF 50

GLOW -BOOSTING

PRIMING SUNSCREEN

UV

FOR A DEWY

HYDRATED FINISH

Broad Spectrum SPF 50

Sunscreen PA++++

50ml 1.7fl.oz

Directions

Directions for Sunscreen Use

  • apply liberally and evenly 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, especally 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

Warnings Section

Active Ingredients

AVOBENZONE 3.0%

HOMOSALATE 7.0%

OCTISALATE 5.0%

OCTOCRYLENE 8.0%

Inactive Ingredients



Water, Alcohol Denat., Butylene Glycol, Copernicia Cerifera (Carnauba) Wax, Glycerin, Diisopropyl Adipate, Mica, Cetearyl Alcohol, Caprylyl Methicone, Isododecane, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Nylon-6/12, Oryza Sativa (Rice) Bran Wax, Polysorbate 60, Saccharide Isomerate, Squalane, Carnosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Glyceryl Caprylate, Fragrance, Disodium EDTA, Pentylene Glycol, Caprylhydroxamic Acid, Triethanolamine, Lactic Acid, Sorbitan Isostearate, Sodium Citrate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

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

Use (USE)

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 44425-7 (44425-7)

Other Information

Other information protect the product in this container from excessive heat and direct sun

Section 50567-7 (50567-7)

Keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

For External Use Only

Section 51945-4 (51945-4)

ULTRA

VIOLETTE

SEQUIN SUPREME SPF 50

GLOW -BOOSTING

PRIMING SUNSCREEN

UV

FOR A DEWY

HYDRATED FINISH

Broad Spectrum SPF 50

Sunscreen PA++++

50ml 1.7fl.oz

Purpose

SUNSCREEN

Directions

Directions for Sunscreen Use

  • apply liberally and evenly 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, especally 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

Warnings Section (WARNINGS SECTION)

Active Ingredients (ACTIVE INGREDIENTS)

AVOBENZONE 3.0%

HOMOSALATE 7.0%

OCTISALATE 5.0%

OCTOCRYLENE 8.0%

Inactive Ingredients



Water, Alcohol Denat., Butylene Glycol, Copernicia Cerifera (Carnauba) Wax, Glycerin, Diisopropyl Adipate, Mica, Cetearyl Alcohol, Caprylyl Methicone, Isododecane, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Nylon-6/12, Oryza Sativa (Rice) Bran Wax, Polysorbate 60, Saccharide Isomerate, Squalane, Carnosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Glyceryl Caprylate, Fragrance, Disodium EDTA, Pentylene Glycol, Caprylhydroxamic Acid, Triethanolamine, Lactic Acid, Sorbitan Isostearate, Sodium Citrate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

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

All Sections (JSON)