Label: GLO SKIN BEAUTY SOLAR SHADE SPF 50 lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 60541-1200-5 - Packager: Hayden Caleel 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 December 19, 2017
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- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Warnings
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Directions
• apply generously 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• 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 -
Inactive ingredients
Aqua/Water/Eau, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Sodium Chloride, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Cetearyl Olivate, Sorbitan Olivate, Cyclohexasiloxane, Hexyl Laurate, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Dimethicone/Polyglycerin-3 Crosspolymer, Ascorbyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Ascorbic Acid, Citric Acid, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8
- Other Information
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
GLO SKIN BEAUTY SOLAR SHADE SPF 50
glo skin beauty solar shade spf 50 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60541-1200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.5 g in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 8.6 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) C12-15 ALCOHOLS (UNII: 2C8M6XLB5C) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HEXYL LAURATE (UNII: 4CG9F9W01Q) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ASCORBYL PALMITATE (UNII: QN83US2B0N) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ETHYLHEXYL PALMITATE (UNII: 2865993309) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID ACETATE (UNII: DSO12WL7AU) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60541-1200-5 1 in 1 CARTON 12/31/2017 1 50 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/31/2017 Labeler - Hayden Caleel LLC (011367468)