Otc - Active Ingredient
Active ingredients
Titanium Dioxide 4.7%
Zinc Oxide 6.0%
Prevention Daily Tinted Moisturizer Spf 30 Cream
FDA Label NDC 62742-4221
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Prevention Daily Tinted Moisturizer Spf 30 (NDC 62742-4221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - 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.
Package Label.Principal Display Panel
Prevention Daily Tinted Moisturizer Spf 30 (Preventiontinted)
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