Label: SUNSCREEN SPRAYS- ethylhexyl methoxycinnamate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 82080-101-01 - Packager: Headblock 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 July 1, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient(s)
- Purpose
- Use
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Warnings
Spray away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away. Caution: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate.Store at temperature below 120F (48℃). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
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Directions
Shake well before use. Apply liberally 15 minutes before sun exposure and rub into skin. Hold container 4 to 6 inches from the skin to apply. Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions. Use in well-ventilated area. Reapply: After 80 minutes of swimming or sweating, immediately after towel drying, or at least every 2 hours. Children under 6 months: Ask a doctor. Other Information: protect this product from excessive heat and direct sun; may stain some fabrics.
- Other information
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Inactive ingredients
Butane,propane, isobutene, water, cyclopentasiloxane, isohexadecane, alcohol, zincoxide, silica, triethoxycaprylylsilane cyclopentasiloxane, peg/ppg-18/18 dimethicone, dimethicone, methylene bis-benzotriazolyl tetramethylbutylphenol, decyl glucoside, propylene glycol, xanthan gum, C12-15 alkyl benzoate, phenylbenzimidazole sulfonic acid, dioctyldodecyl lauroyl glutamate, polysilicone-15,sodium chloride, sodium hydroxide, cetyl peg/ppg -10/1 dimethicone, butylene glycol, centella asiatica extract, polygonum cuspidatum root extract, polygonum cuspidatum root extract,scutellaria baicalensis root extract,camellia sinensis leaf extract, glycyrrhiza glabra,(licorice) root extract, rosmarinus officinalis (rosemary) leaf extract, chamomilla recutita(matricaria) flower extract, 1,2-hexanediol, phenoxyethanol, citrus paradisi (grapefruit) peel oil, tocopherol,disodium edta
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SUNSCREEN SPRAYS
ethylhexyl methoxycinnamate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82080-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIMETHICONE (UNII: 92RU3N3Y1O) BISOCTRIZOLE (UNII: 8NT850T0YS) ENSULIZOLE (UNII: 9YQ9DI1W42) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ISOHEXADECANE (UNII: 918X1OUF1E) ZINC OXIDE (UNII: SOI2LOH54Z) XANTHAN GUM (UNII: TTV12P4NEE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYSILICONE-15 (UNII: F8DRP5BB29) DIOCTYLDODECYL LAUROYL GLUTAMATE (UNII: 3R59HY10WK) SODIUM CHLORIDE (UNII: 451W47IQ8X) ROSEMARY (UNII: IJ67X351P9) CHAMOMILE (UNII: FGL3685T2X) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PHENOXYETHANOL (UNII: HIE492ZZ3T) GRAPEFRUIT OIL (UNII: YR377U58W9) WATER (UNII: 059QF0KO0R) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) ISOBUTANE (UNII: BXR49TP611) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82080-101-01 141 g in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/02/2021 Labeler - Headblock LLC (055858698) Establishment Name Address ID/FEI Business Operations Headblock LLC 055858698 manufacture(82080-101)
