Label: BLUE LIZARD KIDS SPF 50- zinc oxide spray
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- NDC Code(s): 0316-2081-05, 0316-2081-45
- 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 January 28, 2022
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- Active Ingredients
- Purpose
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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 risk of skin cancer and early skin aging caused by the sun.
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Warnings
• For external use only. Contents under pressure. Do not puncture or incinerate.
• Flammable: Keep away from fire or flame.
• When using this product • Keep out of eyes. Rinse with water to remove
• Stop use and ask doctor if • Rash or irritation occurs
• Do not use • On damaged or broken skin • If allergic to any ingredient
• If swallowed, get medical help or contact a Poison Control Center
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Directions
• Shake well prior to use.
• Apply liberally to dry skin 15 minutes before sun exposure
• Hold container 4 to 6 inches from the skin to apply. Rub in. Do not spray directly into face. Spray on hands then apply to face. Rub in.
• Do not apply in windy conditions. • Use in well-ventilated area and avoid inhalation.
• For topical use only • Keep out of reach of children • Children under 6 months of age: 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
Butyloctyl Salicylate, C9-12 Alkane, Caprylic/Capric Triglyceride, Caprylyl Glycol, Diisopropyl Adipate, Dimethicone Crosspolymer-3, Di-PPG-3 Myristyl Ether Adipate, Dunaliella Salina Extract, Ethylhexyl Palmitate, Haematococcus Pluvialis Extract, Phenoxyethanol, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Quaternium-90 Montmorillonite, Quaternium-90 Sepiolite, Tetrafluoropropene, Triethoxycaprylylsilane
- Questions?
- Blue Lizard Kids SPF 50+ Spray 5 oz Label
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INGREDIENTS AND APPEARANCE
BLUE LIZARD KIDS SPF 50
zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-2081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24 mg in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) PHENOXYETHANOL (UNII: HIE492ZZ3T) DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) CAPRYLYL GLYCOL (UNII: 00YIU5438U) KARUM SEED OIL (UNII: 62160PU6FJ) DUNALIELLA SALINA (UNII: F4O1DKI9A6) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYL PALMITATE (UNII: 2865993309) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) DODECANE (UNII: 11A386X1QH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8) QUATERNIUM-90 MONTMORILLONITE (UNII: 7BL4KVZ54U) QUATERNIUM-90 SEPIOLITE (UNII: J9ULC97SE5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-2081-05 142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/29/2021 2 NDC:0316-2081-45 127.6 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/29/2021 Labeler - Crown Laboratories (079035945) Registrant - Crown Laboratories (079035945)
