Label: IT COSMETICS YOUR SKIN BUT BETTER CC PLUS COLOR CORRECTING BROAD SPECTRUM SPF 50 PLUS SUNSCREEN FULL COVERAGE DEEP FAIRLIGHT NEUTRAL TAN RICH HONEY LIGHTMEDIUM AND NEUTRAL MEDIUM- titanium dioxide and zinc oxide cream
- NDC Code(s): 69259-7524-1, 69259-7524-2, 69259-7524-3, 69259-7524-4
- Packager: IT COSMETICS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 30, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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.
-
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
-
Inactive ingredients
water, snail secretion filtrate, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylated/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethiocone, cyclopentasiloxane, cyclohexasiloxane, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/vinyl dimethicone crosspolymer, aluminum hydroxide, hexyl laurate, stearic acid, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethylhexylglycerin, citrus medica limonum (lemon) peel oil, tocopheryl acetate, sorbitan isostearate, phenoxyethanol, citrus aurantium bergamia (bergamot) fruit oil, 1,2-hexanediol, disodium EDTA, citrus aurantium dulcis (orange) peel oil, cirus aurantifolia (lime) oil vitis vinifera (grape) seed oil, punica gratissiima (avocado) oil, niacinamide, citrus grandis (grapefuit) peel oil, chloesterol, anthemis b=nobilis flower water, lactobacillius/honeysuckle flowr/locorice root/morus alba root/pueraria lobata root/schizandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, perfluorohexane, olea europaea (olive) leaf extract, glycerin, eucalyptus globulus leaf oil, camellia sinensis leaf extract, chrysanthemium indicum flower extract, pueraria lobata root extract, perfluorodecalin, morus alba gruit extract, magnolia kobus bark extract, glycine soja (soybean) sprout extract, diospyros kaki leaf extract, cinnamomum cassia bark extract, artemisia princeps leaf extract, epntafluoropropane, curcuma longa (turmeric) root extract, steareth-20, hydrolyzed silk, hydrolyzed hyaluronic acid, colloidal oatmeal, citric acid, sodium benzoate, potassum sorbate, aloe barbadensis leaf extract, n-hydroxysuccinimide, hydrolyzed collagen, caprylhydroxamic acid, tocopherol, thiamine HCL, riboflavin, retinyl palmitate, pantothenic acid, palmitoyl oligopeptide, nicin, folic acid, chrysin, carnitine HCL, biotin, ascorbic acid, palmitoyl tetrapeptide-7, chlorhexidine digluconate; may contain: iron oxides
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IT COSMETICS YOUR SKIN BUT BETTER CC PLUS COLOR CORRECTING BROAD SPECTRUM SPF 50 PLUS SUNSCREEN FULL COVERAGE DEEP FAIRLIGHT NEUTRAL TAN RICH HONEY LIGHTMEDIUM AND NEUTRAL MEDIUM
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69259-7524 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 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) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HEXYL LAURATE (UNII: 4CG9F9W01Q) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM STEARATE (UNII: 776XM7047L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LEMON OIL (UNII: I9GRO824LL) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SORBITAN (UNII: 6O92ICV9RU) ISOSTEARETH-5 (UNII: 3M721D059Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) BERGAMOT OIL (UNII: 39W1PKE3JI) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) AVOCADO OIL (UNII: 6VNO72PFC1) NIACINAMIDE (UNII: 25X51I8RD4) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) CHOLESTEROL (UNII: 97C5T2UQ7J) PERFLEXANE (UNII: FX3WJ41CMX) GLYCERIN (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PERFLUNAFENE (UNII: 54A06VV62N) STEARETH-20 (UNII: L0Q8IK9E08) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) TOCOPHEROL (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) RIBOFLAVIN (UNII: TLM2976OFR) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PANTOTHENIC ACID (UNII: 19F5HK2737) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) NIACIN (UNII: 2679MF687A) FOLIC ACID (UNII: 935E97BOY8) CHRYSIN (UNII: 3CN01F5ZJ5) LEVOCARNITINE HYDROCHLORIDE (UNII: J3Y5E6IKS3) BIOTIN (UNII: 6SO6U10H04) ASCORBIC ACID (UNII: PQ6CK8PD0R) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69259-7524-1 1 in 1 CARTON 03/14/2018 1 32 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69259-7524-2 1 in 1 CARTON 03/14/2018 2 75 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69259-7524-3 1 in 1 CARTON 03/14/2018 3 12 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:69259-7524-4 1 in 1 CARTON 03/14/2018 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 03/14/2018 Labeler - IT COSMETICS, LLC (962591793)
