DAILY PREVENTION PURE MINERAL HYDRATING MOISTURIZER SPF30- zinc oxide cream

Daily Prevention Pure Mineral Hydrating Moisturizer SPF30 by

Drug Labeling and Warnings

Daily Prevention Pure Mineral Hydrating Moisturizer SPF30 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 :

Zinc Oxide 18.1%

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

Water /Aqua/Eau, Cyclopentasiloxane, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Dimethicone, Glycerin, Lecithin, Isohexadecane, Aloe Barbadensis Leaf Juice, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Magnesium Sulfate Heptahydrate, Acetyl Zingerone, Phenoxyethanol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Camellia Sinensis Leaf Extract, Methyl Propanediol, Sodium Hyaluronate, Polysorbate 60,Ectoin,Sodium Citrate,Sorbitan Isostearate, Tocopherol, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAILY PREVENTION PURE MINERAL HYDRATING MOISTURIZER SPF30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4245
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOHEXADECANE (UNII: 918X1OUF1E)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PALMITIC ACID (UNII: 2V16EO95H1)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACETYL ZINGERONE (UNII: V9D92S9YE5)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MANNITOL (UNII: 3OWL53L36A)
VANILLA (UNII: Q74T35078H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
PHENYLPROPANOL (UNII: 0F897O3O4M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
PANTHENOL (UNII: WV9CM0O67Z)
SQUALANE (UNII: GW89575KF9)
PHOSPHATIDYLCHOLINE TRANSLOCATOR ABCB4 (UNII: 9EI49ZU76O)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ECTOINE (UNII: 7GXZ3858RY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4245-1	7 g in 1 TUBE; Type 0: Not a Combination Product	02/22/2024
2	NDC: 62742-4245-2	142 g in 1 TUBE; Type 0: Not a Combination Product	02/22/2024
3	NDC: 62742-4245-4	1 in 1 CARTON	02/22/2024
3	NDC: 62742-4245-3	73 g in 1 TUBE; 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	02/22/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4245)