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

Prevention Daily Tinted Moisturizer SPF 30 by

Drug Labeling and Warnings

Prevention Daily Tinted Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. 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

Indication and usage

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 at least every 2 hours

use a water resistant sunscreen if swimming or sweating

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

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

INACTIVE INGREDIENT

Inactive ingredients AQUA/WATER/EAU, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERIN, CYCLOHEXASILOXANE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINUM HYDROXIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, STEARIC ACID, SODIUM CHLORIDE, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, PHENOXYETHANOL, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, IRON OXIDES (CI 77492), LIMONENE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, SORBITAN OLIVATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, TOCOPHERYL ACETATE, IRON OXIDES (CI 77491), CAMELLIA SINENSIS LEAF EXTRACT, IRON OXIDES (CI 77499), BENZOIC ACID, DIPROPYLENE GLYCOL, TITANIUM DIOXIDE (CI 77891), ARTEMISIA VULGARIS EXTRACT, LAMINARIA DIGITATA EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, TRIETHOXYCAPRYLYLSILANE, SODIUM CITRATE, GLUCOSE, HYDROLYZED PEA PROTEIN, TOCOPHEROL, BAROSMA BETULINA LEAF OIL, TETRAHEXYLDECYL ASCORBATE, ALUMINA, MAGNESIUM OXIDE, SODIUM SUCCINATE, POTASSIUM SORBATE, SODIUM BENZOATE, LECITHIN, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM FERROCYANIDE, ARABIDOPSIS THALIANA EXTRACT, MICROCOCCUS LYSATE, PLANKTON EXTRACT, ERGOTHIONEINE.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4221
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
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ORANGE OIL (UNII: AKN3KSD11B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TOCOPHEROL (UNII: R0ZB2556P8)
AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SODIUM FERROCYANIDE (UNII: 5HT6X21AID)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MANDARIN OIL (UNII: NJO720F72R)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PEA PROTEIN (UNII: 7Q50F46595)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
VANILLA (UNII: Q74T35078H)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4221-1	7 g in 1 TUBE; Type 0: Not a Combination Product	11/15/2022
2	NDC: 62742-4221-3	1 in 1 CARTON	11/15/2022
2	NDC: 62742-4221-2	91 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 final	M020	11/15/2022

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs Inc		926831603	manufacture(62742-4221)