Sun Sublime Protective Face Care SPF 30

Manufacturer
Naos USA, Inc.
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:19:48

Label at a glance#

ProductSun Sublime Protective Face Care SPF 30
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE
Label structure8 sections

Dosage and administration

Adults 18 years and older: 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 incl...

Label contents#

Full prescribing information#

Active ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Homosalate 9%
Octisalate 4.5%
Avobenzone 2.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on broken skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years and older:

  • 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, especially from 10 a.m. - 2 p.m. ; and
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months of age: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Keep the product between 15-30ºC (59-86ºF). • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/water/eau, Ethylhexyl Methoxycrylene, Glycerin, Glyceryl Stearate, Coco-caprylate/caprate, Propanediol, Silica, Dimethicone, Caprylyl
Methicone, Peg-100 Stearate, Butyloctyl Salicylate, Cera alba/beeswax/cire d´abeille, Tocopheryl Acetate, Cetyl Alcohol, Benzotriazolyl Dodecyl P-cresol, Oryzanol, Pentylene Glycol, Vp/eicosene Copolymer, Fragrance (Parfum), Glycyrrhetinic Acid, Mannitol, Methylpropanediol, Oryza Sativa  (Rice) Bran Oil, Pongamol, Soybean Glycerides, Polysilicone-11, Butylene Glycol, Acetyl Tyrosine, Aspartic Acid, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Polyacrylate Crosspolymer-6, Sodium Citrate, Sodium Dextran Sulfate, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Xanthan Gum, Creatine, Dipropylene Glycol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Hydrolyzed Wheat Protein, Luffa Cylindrica Seed Oil, Oleic Acid, Propylene Glycol, Aminoethanesulfinic Acid, Phenoxyethanol, Carbomer, Sodium Lactate, Caprylyl Glycol, Polysorbate 20, Copper Gluconate, Asiaticoside, Madecassic Acid, Carnosine, Tocopherol, Asiatic Acid, Disodium  Adenosine Triphosphate, Artemia Extract, Medicago Sativa (Alfalfa) Extract, Laminaria Digitata Extract, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Acetyl Hexapeptide-1, Dextran, Linalool, Hexyl Cinnamal, Hydroxycitronellal, Limonene, Benzyl Benzoate, Geraniol, Citronellol, Isoeugenol, Coumarin, Citral.

Questions?

OTC - QUESTIONS SECTION

Call 1-877-443-3762

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package3Outer Package3Inner Package3Inner Package3

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14324-02714324-027-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 70 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b419ba3-48d6-8df0-e063-6294a90a741ced1d8617-e081-4775-81ef-1591106be02d2023-11-28WarningsExact identifier
spl id: 0b419ba3-48d6-8df0-e063-6294a90a741c
spl set id: ed1d8617-e081-4775-81ef-1591106be02d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.