DAILY PREVENTION PROTECT AND REFRESH MIST SPF 40- avobenzone, octisalate and octocrylene spray

Daily Prevention Protect and Refresh Mist SPF 40 by

Drug Labeling and Warnings

Daily Prevention Protect and Refresh Mist SPF 40 by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 2.9%

Octisalate 4.9%

Octocrylene 9.5%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

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

Warnings: Flammable. Keep away from fire or flame. For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions shake well before use hold container 4 to 6 inches from the skin to apply spray liberally and spread evenly by hand 15 minutes before sun exposure avoid contact with eyes reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: ask a doctor 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

OTHER SAFETY INFORMATION

Other information protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients: Alcohol, Diisooctyl Succinate, Butyloctyl Salicylate, Aqua/water/Eau, Ethylhexyl Methoxycrylene, VA/Butyl Maleate/ Isobornyl Acrylate Copolymer, Alcohol Denat., Acetyl Zingerone, Caprylie/Capric Triglyceride, Ethyl Ferulate, Polyester-8, Mauritia Flexuosa Fruit Oil, Limnanthes Alba Seed Oil, Glycerin, Brassica Campestris Seed Oil, Rubus Idaeus Seed Oil, T-Butyl Alcohol, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra Root Extract, Polyglyceryl-3 Diisostearate, Opuntia Ficus-Indica Leaf Cell Extract, Camellia Sinensis Leaf Extract, Bisabolol, Phosphatidylcholine, Althaea Officinalis Root Extract, Oryza Sativa Bran Extract, Mannitol, Methylpropanediol, Ectoin, Caprylyl Glycol, Denatonium Benzoate, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAILY PREVENTION PROTECT AND REFRESH MIST SPF 40 
avobenzone, octisalate and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OPUNTIA FICUS-INDICA LEAF (UNII: 5VM709H93V)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIISOBUTYL SUCCINATE (UNII: 1241X4J800)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ACETYL ZINGERONE (UNII: V9D92S9YE5)
STEARIC ACID (UNII: 4ELV7Z65AP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYL FERULATE (UNII: 5B8915UELW)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PANTHENOL (UNII: WV9CM0O67Z)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
LEVOMENOL (UNII: 24WE03BX2T)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ECTOINE (UNII: 7GXZ3858RY)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
VANILLA BEAN (UNII: Q74T35078H)
RICE BRAN (UNII: R60QEP13IC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
GLYCERIN (UNII: PDC6A3C0OX)
BRASSICA RAPA SUBSP. RAPA SEED (UNII: 728X944L6M)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PHENYLPROPANOL (UNII: 0F897O3O4M)
PHOSPHATIDYLCHOLINE TRANSLOCATOR ABCB4 (UNII: 9EI49ZU76O)
MANNITOL (UNII: 3OWL53L36A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4257-2	1 in 1 CARTON	03/21/2024
1	NDC: 62742-4257-1	100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/21/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4257)