Label: BLISS BLOCK STAR SHEER LIQUID DAILY SUNSCREEN SPF 50 SPF-50- zinc oxide lotion
- NDC Code(s): 67038-203-60
- Packager: Bliss Products Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 16, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
• Apply liberally 15 minutes before sun exposure • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 - STORAGE AND HANDLING
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INACTIVE INGREDIENT
Water, Caprylic/Capric Triglyceride, Glycerin, VP/Hexadecene Copolymer, Dimethicone, Sorbitan Isostearate, Helianthus Annuus (Sunflower) Seed Oil, Bisabolol, Xanthan Gum, Cetearyl Alcohol, Ethyl Ferulate, Olive Oil Polyglyceryl-6 Esters, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Stearate, Polysorbate 60, Polysorbate 80, Sodium Stearoyl Lactylate, Triethoxycaprylylsilane, Isohexadecane, Gluconolactone, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Sodium Benzoate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BLISS BLOCK STAR SHEER LIQUID DAILY SUNSCREEN SPF 50 SPF-50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67038-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLIC/CAPRIC ACID (UNII: DI775RT244) WATER (UNII: 059QF0KO0R) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ISOHEXADECANE (UNII: 918X1OUF1E) GLUCONOLACTONE (UNII: WQ29KQ9POT) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) SUNFLOWER OIL (UNII: 3W1JG795YI) XANTHAN GUM (UNII: TTV12P4NEE) ETHYL FERULATE (UNII: 5B8915UELW) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) PEG-20 SORBITAN ISOSTEARATE (UNII: X958PZJ9ON) BISABOLOL OXIDE A (UNII: 16AE65F94Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67038-203-60 1 in 1 BOX 01/31/2023 1 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/31/2023 Labeler - Bliss Products Holdings LLC (117126047)
