Label: PREVENTION DAILY TINTED MOISTURIZER SPF 30- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4221-1, 62742-4221-2, 62742-4221-3
- Packager: Allure Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 15, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
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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
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INGREDIENTS AND APPEARANCE
PREVENTION DAILY TINTED MOISTURIZER SPF 30
zinc oxide and titanium dioxide creamProduct 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)
