DAILY PREVENTION ULTRA DEFENSE MOISTURIZER SPF 50- homosalate, octisalate,octocrylene and zinc oxide cream 
Allure Labs

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Drug Facts

Active ingredients

Homosalate 7.3%

Octisalate 5.0%

Octocrylene 9.9%

Zinc Oxide 7.0%

Purpose; Sunscreen

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 • For external use only

Do not use • on damaged or broken skin

When using this product • 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.

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 information • protect the product in this container from excessive heat and direct sun • Due to the presence of botanical ingredients, this product may change in color over time.

Inactive ingredients : Aqua/Water/Eau, Cetyl PEG/PPG-10/1 Dimethicone, Hydrogenated Ethylhexyl Olivete, C12-15 Alkyl Benzoate, C13-15 Alkane, Theobroma Cacao Seed Butter, Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Ethylhexyl Stearate, Isoamyl Laurate, Glycerin, Ethylhexyl Palmitate, Phenoxyethanol, Euphorbia Cerifera Wax, Polyhydroxystearic Acid, Sodium Chloride, Acetyl Zingerone, Caprylic/Capric Triglyceride, Hydrogenated Olive Oil Unsaponifiables, Tocopheryl Acetate, Ethylhexylglycerin, Hydrated Silica, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Methyl Propanediol, Benzoic Acid, Ectoin, Palmitic Acid, Caprylyl Glycol, Stearic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Pentaerythrityl Tetra-Di-T-Butyl Hydroxydrocinnamate.

Daily Prevention Ultra Defense Moisturizer SPF 50

DAILY PREVENTION ULTRA DEFENSE MOISTURIZER SPF 50 
homosalate, octisalate,octocrylene and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4255
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.9 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
C13-15 ALKANE (UNII: 114P5I43UJ)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ECTOINE (UNII: 7GXZ3858RY)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
VANILLA (UNII: Q74T35078H)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
PHOSPHATIDYLCHOLINE TRANSLOCATOR ABCB4 (UNII: 9EI49ZU76O)  
MANNITOL (UNII: 3OWL53L36A)  
WATER (UNII: 059QF0KO0R)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
ACETYL ZINGERONE (UNII: V9D92S9YE5)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
COCOA BUTTER (UNII: 512OYT1CRR)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CANDELILLA WAX (UNII: WL0328HX19)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROGENATED ETHYLHEXYL OLIVATE (UNII: JBH5K4WD8L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PALMITIC ACID (UNII: 2V16EO95H1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4255-17 g in 1 TUBE; Type 0: Not a Combination Product03/19/2024
2NDC:62742-4255-31 in 1 CARTON03/19/2024
2NDC:62742-4255-273 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:62742-4255-4142 g in 1 TUBE; Type 0: Not a Combination Product03/19/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/19/2024
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4255)

Revised: 3/2024
Document Id: 14070076-8c58-e2f1-e063-6394a90a0dfc
Set id: 14070076-8c57-e2f1-e063-6394a90a0dfc
Version: 1
Effective Time: 20240319
 
Allure Labs