DAILY PREVENTION PURE MINERAL TINTED MOISTURIZER SPF 30- titanium dioxide and zinc oxide cream

Daily Prevention Pure Mineral Tinted Moisturizer SPF 30 by

Drug Labeling and Warnings

Daily Prevention Pure Mineral Tinted Moisturizer SPF 30 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

Titanium Dioxide 4.7%

Zinc Oxide 6.0%

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

DOSAGE & ADMINISTRATION

Directions apply generously 15 minutes before sun exposure children under 6 months of age: Ask a doctor reapply: after 40 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.

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.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredients: Agua/Water/Eau, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone /PEG-10/15 Crosspolymer, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Cetearyl Olivate, Acetyl Zingerone, PolyglyceryI-4 lsostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Dimethicone/Polyglycerin-3 Crosspolymer, Phenoxyethanol, Sorbitan Oliveto, Caprylic/Capric Triglyceride, Triethoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Camellia Sinensis Leaf Extract, Dipropylene Glycol, Benzoic Acid, Methyl Propanediol, Triethoxycapryiyisilane, Sodium Citrate, Ectoin, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tocopherol, Tatrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Alumina, Magnesium Oxide, Sodium Benzoate, Potassium Sorbate, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Ferrocyanide, CI 77891, CI 77499, CI 77492, CI 77491.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAILY PREVENTION PURE MINERAL TINTED MOISTURIZER SPF 30 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACETYL ZINGERONE (UNII: V9D92S9YE5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
SODIUM FERROCYANIDE (UNII: 5HT6X21AID)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
MANNITOL (UNII: 3OWL53L36A)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ECTOINE (UNII: 7GXZ3858RY)
PALMITIC ACID (UNII: 2V16EO95H1)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PANTHENOL (UNII: WV9CM0O67Z)
VANILLA (UNII: Q74T35078H)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHOSPHATIDYLCHOLINE TRANSLOCATOR ABCB4 (UNII: 9EI49ZU76O)
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4254-1	7 g in 1 TUBE; Type 0: Not a Combination Product	03/15/2024
2	NDC: 62742-4254-3	1 in 1 CARTON	03/15/2024
2	NDC: 62742-4254-2	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	03/15/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4254)