NDC | 69259-2522-1, 69259-2522-2, 69259-2522-3, 69259-2522-4 |
Set ID | b7d184fb-4a9a-4720-9b00-bf0caa257a8c |
Category | HUMAN OTC DRUG LABEL |
Packager | IT COSMETICS, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
For sunscreen use:
● apply liberally 15 minutes before sun exposure
● 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
● children under 6 months of age: Ask a doctor - Other information
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Inactive ingredients
water, dimethicone, butylene glycol dicaprylate/dicaprate, butylene glycol, cyclopentasiloxane, dimethicone/vinyl dimethicone crosspolymer, butyloctyl salicylate, cetyl PEG/PPGg-10/1 dimethicone, snail secretion filtrate, sodium chloride, bis-diglyceryl polyacyladipate-2, aluminum hydroxide, stearic acid, disteardimonium hectorite, sorbitan isostearate, polyglyceryl-4 isostearate, hexyl laurate, triethoxycaprylylsilane, triethyl citrate, ethyl hexanediol, sodium benzoate, potassium sorbate, polymethylsilsesquioxane, tocopheryl acetate, phenoxyethanol, disodium EDTA, canadian colloidal clay, moroccan lava clay, avena sativa (oat) kernel extract, glycerin, niacinamide, curcuma longa (turmeric) root extract, sulfur, cholesterol, anthemis nobilis flower water, perfluorohexane, persea gratissima (avocado) fruit extract, maltodextrin, 1,2-hexanediol, vitis vinifera (grape) seed extract, camellia sinensis leaf extract, salix alba (willow) bark extract, magnolia kobus bark extract, chrysanthemum indicum flower extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, aloe barbadensis leaf extract, perfluoromethylcyclopentane, citric acid, olea europaea (olive) leaf extract, artemisia princeps leaf extract, cinnamomum cassia bark extract, pueraria lobata root extract, diospyros kaki leaf extract, morus alba fruit extract, steareth-20, melaleuca alternifolia (tea tree) flower/leaf/stem extract, punica granatum fruit juice, hydrolyzed collagen, ethylhexylglycerin, charcoal powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, chlorhexidine digluconate, n-hydroxysuccinimide, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7; may contain: iron oxides, titanium dioxide
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IT COSMETICS YOUR SKIN BUT BETTER CC PLUS OIL FREE MATTE PORELESS FINISH FULL COVERAGE BROAD SPECTRUM SPF 40 SUNSCREEN ALL SHADES
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69259-2522 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 74 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) ETHOHEXADIOL (UNII: M9JGK7U88V) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) SULFUR (UNII: 70FD1KFU70) CHOLESTEROL (UNII: 97C5T2UQ7J) PERFLEXANE (UNII: FX3WJ41CMX) MALTODEXTRIN (UNII: 7CVR7L4A2D) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) VITIS VINIFERA ANTHOCYANINS (UNII: F02KPB2508) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PERFLUNAFENE (UNII: 54A06VV62N) ALOE VERA LEAF (UNII: ZY81Z83H0X) PERFLUOROMETHYLCYCLOPENTANE (UNII: 8S014W4T75) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CHINESE CINNAMON (UNII: WS4CQ062KM) STEARETH-20 (UNII: L0Q8IK9E08) POMEGRANATE JUICE (UNII: 99S671U9KB) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) CHLORHEXIDINE (UNII: R4KO0DY52L) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) CHRYSIN (UNII: 3CN01F5ZJ5) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69259-2522-1 1 in 1 CARTON 07/01/2018 1 32 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69259-2522-2 1 in 1 CARTON 07/01/2018 2 75 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69259-2522-3 1 in 1 CARTON 07/01/2018 3 12 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:69259-2522-4 1 in 1 CARTON 07/01/2018 4 4 mL 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 not final part352 07/01/2018 Labeler - IT COSMETICS, LLC (962591793)