SUNSCREEN SPRAYS- ethylhexyl methoxycinnamate spray

sunscreen sprays by

Drug Labeling and Warnings

sunscreen sprays by is a Otc medication manufactured, distributed, or labeled by Headblock LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

sunscreen sprays

Active Ingredient(s)

ETHYLHEXYL METHOXYCINNAMATE 5% w/w. Purpose: Sunscreen

Purpose

Sunscreen, sunscreen sprays

Use

Helps prevent sunburn.If used as directed with other sun protection measures,

decreases the risk of skin cancer and early skin aging caused by the sun.

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.

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

Uses: Helps prevent sunburn; if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

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

INGREDIENTS AND APPEARANCE

SUNSCREEN SPRAYS 
ethylhexyl methoxycinnamate spray

Product 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)