Label: SHEER FLUID SUN SHIELD BROAD SPECTRUM SPF 30- octinoxate and zinc oxide liquid
- NDC Code(s): 72704-108-01
- Packager: Lancer Skincare LLC.
- 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 19, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
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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
- Children under 6 months of age: Ask a doctor
- Other Information
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Inactive Ingredients
Cyclopentasiloxane, Water (Aqua), Alcohol Denat., Glycerin, Methyl Methacrylate Crosspolymer, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Vitis Vinifera (Grape) Fruit Cell Extract, Zingiber Officinale (Ginger) Root Extract, Tropaeolum Majus Extract, Helianthus Annuus (Sunflower) Sprout Extract, Bisabolol, Tocopherol, Lecithin, PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Benzylidene Dimethoxydimethylindanone, Isomalt, Hexylene Glycol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHEER FLUID SUN SHIELD BROAD SPECTRUM SPF 30
octinoxate and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72704-108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 17.1 g in 100 mL Inactive Ingredients Ingredient Name Strength Cyclomethicone 5 (UNII: 0THT5PCI0R) Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Glycerin (UNII: PDC6A3C0OX) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794) Grape (UNII: 6X543N684K) Ginger (UNII: C5529G5JPQ) Tropaeolum Majus Whole (UNII: 9G6ZOS4L87) Helianthus Annuus Sprout (UNII: 4P26HG1S5W) Levomenol (UNII: 24WE03BX2T) Tocopherol (UNII: R0ZB2556P8) PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: TYP81E471F) Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone (UNII: X75PL53TZJ) Benzylidene Dimethoxydimethylindanone (UNII: 75HIF3C97L) Isomalt (UNII: S870P55O2W) Hexylene Glycol (UNII: KEH0A3F75J) Caprylyl Glycol (UNII: 00YIU5438U) Ethylhexylglycerin (UNII: 147D247K3P) Phenoxyethanol (UNII: HIE492ZZ3T) Lecithin, soybean (UNII: 1DI56QDM62) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72704-108-01 1 in 1 CARTON 11/01/2016 1 60 mL in 1 BOTTLE; 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 11/01/2016 Labeler - Lancer Skincare LLC. (079089155) Establishment Name Address ID/FEI Business Operations Vege-Labs 117878620 MANUFACTURE(72704-108)
