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

Daily Prevention Ultra Defense Moisturizer SPF 50 by

Drug Labeling and Warnings

Daily Prevention Ultra Defense Moisturizer SPF 50 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

Homosalate 7.3%

Octisalate 5.0%

Octocrylene 9.9%

Zinc Oxide 7.0%

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 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 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 SAFETY INFORMATION

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 INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.9 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4255-1	7 g in 1 TUBE; Type 0: Not a Combination Product	03/19/2024
2	NDC: 62742-4255-3	1 in 1 CARTON	03/19/2024
2	NDC: 62742-4255-2	73 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 62742-4255-4	142 g in 1 TUBE; Type 0: Not a Combination Product	03/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/19/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4255)