Label: BLUE LIZARD SPORT SPF 50 SUNSCREEN- octisalate and titanium dioxide and zinc oxide lotion
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- NDC Code(s): 0316-2075-30, 0316-2075-40, 0316-2075-45, 0316-2075-50
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 13, 2023
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- Active Ingredients
- Purpose
-
Uses
- Helps prevent sunburn and photodamage caused by UVA/UVB exposure
- Higher SPF gives more sunburn protection
- If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
• Shake well prior to use
• Apply liberally to dry skin 15 minutes before sun exposure
• For topical use only
• Keep out of reach of children • Children under 6 months: ask a doctor
• 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.
• Reapply to dry skin: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
- Other Information
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Inactive Ingredients
Alumina, Aluminum Stearate, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Capylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Sebacate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexyl Laurate, Hydrogenated Castor Oil, Isostearyl Isostearate, L-Arginine, Methyl Glucose Dioleate, Methylpropanediol, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polyurethane-35, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer
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INGREDIENTS AND APPEARANCE
BLUE LIZARD SPORT SPF 50 SUNSCREEN
octisalate and titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-2075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 55.5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 59.5 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 111 mg in 1 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STEARATE (UNII: U6XF9NP8HM) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) YELLOW WAX (UNII: 2ZA36H0S2V) ARGININE (UNII: 94ZLA3W45F) METHYLPROPANEDIOL (UNII: N8F53B3R4R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYL LAURATE (UNII: 4CG9F9W01Q) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENYLPROPANOL (UNII: 0F897O3O4M) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) POLYURETHANE-35 (NOT MORE THAN 500 MPA.S AT 40%) (UNII: Q2LKX89BE0) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-2075-30 89 mL in 1 TUBE; Type 0: Not a Combination Product 02/09/2021 2 NDC:0316-2075-50 259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2021 3 NDC:0316-2075-45 148 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2021 05/01/2021 4 NDC:0316-2075-40 1 in 1 CARTON 03/04/2021 4 148 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 not final part352 02/09/2021 Labeler - Crown Laboratories (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories 079035945 manufacture(0316-2075)
