Label: ALL PHYSICAL SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 10477-1003-1, 10477-1003-2, 10477-1003-3 - Packager: Goodier 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 October 15, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
Intellishade®
TruPhysical™
A breakthrough daily moisturizer with anti-aging technology that leaves skin instantly glowing and
appearing more youthful and brighter over time.Helps reduce and prevent visible signs of aging with a powerful blend of 3 bioavailable peptides,
botanical extracts and antioxidants.Provides broad spectrum UV protection with ground-breaking,
100% all-mineral technology and no hidden chemical sunscreens.Universal tint blends with all skin tones for a healthy, naturally beautiful look.
Dist. by Revision, LLC – ITC1
Irving, TX 75063 Made in U.S.A. - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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INSTRUCTIONS FOR USE
Directions
• 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: Ask a doctor -
INACTIVE INGREDIENT
Inactive ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment,
Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate,
Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Hydrogenated
Starch Hydrolysate, Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula
Alba (White Birch) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Plankton
Extract, Beeswax, Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate,
Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl
Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl
Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl
Aminobutyroylvalylaminobutyric Urea Tri-uoroacetate, Yeast Extract (Faex), Boron
Nitride, Epigallocatechin Gallate, Ubiquinone, Jojoba Bean Meal, Melanin, Phenoxyethanol,
Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride,
Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, Iron Oxides. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALL PHYSICAL SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10477-1003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) THERMUS THERMOPHILUS (UNII: 415H64SACF) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALOE VERA LEAF (UNII: ZY81Z83H0X) WHITE WAX (UNII: 7G1J5DA97F) SQUALANE (UNII: GW89575KF9) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) BORON NITRIDE (UNII: 2U4T60A6YD) EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL) UBIQUINONE Q2 (UNII: I7T5V2W47R) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) XANTHAN GUM (UNII: TTV12P4NEE) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) BENZOIC ACID (UNII: 8SKN0B0MIM) SORBIC ACID (UNII: X045WJ989B) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10477-1003-1 1 in 1 CARTON 03/05/2018 1 48 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10477-1003-2 227 g in 1 TUBE; Type 0: Not a Combination Product 03/05/2018 3 NDC:10477-1003-3 3 g in 1 TUBE; Type 0: Not a Combination Product 03/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/05/2018 Labeler - Goodier Cosmetics LLC (007317209) Establishment Name Address ID/FEI Business Operations Goodier Cosmetics LLC 007317209 manufacture(10477-1003)
