Label: VERTRA ELEMENTAL RESISTANCE WATER RESISTANT SUNSCREEN- octyl methoxycinnamate, oxybenzone, titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69750-001-80 - Packager: Vertra (Aust) Pty Ltd
- 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 May 18, 2015
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally and evenly 15 minutes before sun exposure
- apply to all skin exposed to sun
- use a water resistant sunscreen if swimming or sweating
- reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours
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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 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m.-2p.m., wear long-sleeve shirts, pants, hats, and sunglasses, children under 6 months of age: ask a doctor
- Other information
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Inactive Ingredients
Acrylates copolymer, Ammonia, C12-15 alkyl benzoate, Cyclomethicone 5, Iodopropynl butylcarbamate, Lauryl PEG/PPG-18/18 methicone, Methyl glucose dioleate, Methlchloroisothiazolinone, Methylisothiazolinone, Phenoxyethanol, Phenyl trimethicone, Polyhydroxystearic acid, Purified water, Silica dimethyl silylate, Silicone dioxide, Sodium chloride, Sodium dodecylbenzenesulfonate, Stearic acid, Triethoxycaprylylsilane, Xanthan gum
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- DESCRIPTION
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INGREDIENTS AND APPEARANCE
VERTRA ELEMENTAL RESISTANCE WATER RESISTANT SUNSCREEN
octyl methoxycinnamate, oxybenzone, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69750-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.8 g in 80 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 80 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5 g in 80 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.9 g in 80 g Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) WATER (UNII: 059QF0KO0R) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69750-001-80 1 in 1 BOTTLE 1 80 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 not final part352 05/18/2015 Labeler - Vertra (Aust) Pty Ltd (743597064) Establishment Name Address ID/FEI Business Operations Delta Laboratories Pty Limited 751231564 manufacture(69750-001)