BLISS BLOCK STAR – INVISIBLE DAILY SUNSCREEN SPF-30: Package Insert and Label Information

BLISS BLOCK STAR — INVISIBLE DAILY SUNSCREEN SPF-30- titanium dioxide and zinc oxide lotion
Bliss Products Holdings LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS

Titanium Dioxide 4.1%
Zinc Oxide 11.5%

PURPOSE

Sunscreen

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.

WARNINGS

  • For external use only
  • 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DIRECTIONS

  • Apply liberally 15 minutes beforesun exposure
  • Reapply:
  • at least every 2 hours
  • use a water-resistant sunscreen if swimming orsweating

  • 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.
  • Wear long-sleeved shirts, pants, hats and sunglasses

INACTIVE INGREDIENTS

Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Dicaprylyl Carbonate, Propylene Glycol Dicaprylate, Disiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, PEG-10 Dimethicone, Sodium Acrylates Crosspolymer-2, Polymethylsilsesquioxane, Butyloctyl Salicylate, Vinyl Dimethicone/ Methicone Silsesquioxane Crosspolymer, Vaccinium Angustifolium (Blueberry) Fruit Extract, Oenothera Biennis (Evening
Primrose) Flower Extract, Euterpe Oleracea Fruit Extract, Hibiscus Sabdariffa Flower Extract, Camellia Sinensis Leaf Extract, Pinus Palustris Leaf Extract, Ulmus Davidiana Root Extract, Pueraria Lobata Root Extract, Enantia Chlorantha Bark Extract, Lavandula Angustifolia (Lavender) Oil, Rosa Canina Fruit Oil, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Oleanolic Acid, Squalane, Glyceryl Caprylate, Aluminum Hydroxide, Polyglyceryl-6 Polyricinoleate, Sorbitan Caprylate, Stearic Acid, Synthetic Fluorphlogopite, Triethoxycaprylylsilane, Dipropylene Glycol, 1,2-Hexanediol, Dimethicone/PEG-10/15 Crosspolymer, Disteardimonium Hectorite, Magnesium Sulfate, Ethylhexylglycerin, Iron Oxides

OTHER INFORMATION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

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01b UC_Invisible Sunscreen SPF30_back
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BLISS BLOCK STAR — INVISIBLE DAILY SUNSCREEN SPF-30
titanium dioxide, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67038-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 4.1 g in 100 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 11.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
BUTYLENE GLYCOL
GLYCERIN
DICAPRYLYL CARBONATE
PROPYLENE GLYCOL DICAPRYLATE
HEXAMETHYLDISILOXANE
MAGNESIUM SULFATE ANHYDROUS
ETHYLHEXYLGLYCERIN
FERROUS OXIDE
SODIUM POLYACRYLATE (8000 MW)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
DIMETHICONE
PEG-10 DIMETHICONE (600 CST)
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
BUTYLOCTYL SALICYLATE
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
BLUEBERRY
OENOTHERA BIENNIS FLOWER
EUTERPE OLERACEA WHOLE
HIBISCUS SABDARIFFA FLOWER
GREEN TEA LEAF
PINUS PALUSTRIS LEAF
ULMUS DAVIDIANA ROOT
PUERARIA MONTANA VAR. LOBATA ROOT
ANNICKIA CHLORANTHA BARK
LAVENDER OIL
ROSA CANINA FRUIT OIL
CHAMAEMELUM NOBILE FLOWER OIL
HYALURONATE SODIUM
OLEANOLIC ACID
SQUALANE
GLYCERYL CAPRYLATE
ALUMINUM HYDROXIDE
POLYGLYCERYL-3 PENTARICINOLEATE
SORBITAN MONOCAPRYLATE
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DIPROPYLENE GLYCOL
1,2-HEXANEDIOL
DIMETHICONE/PEG-10/15 CROSSPOLYMER
DISTEARDIMONIUM HECTORITE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67038-200-40 1 TUBE in 1 BOX contains a TUBE
1 40 mL in 1 TUBE This package is contained within the BOX (67038-200-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/23/2020
Labeler — Bliss Products Holdings LLC (117126047)

Revised: 12/2021 Bliss Products Holdings LLC

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