NDC | 62032-150-10, 62032-150-99 |
Set ID | 6456fc28-3df5-4d49-9f40-8ef2e4fdd9e5 |
Category | HUMAN OTC DRUG LABEL |
Packager | OMP, INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
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- helps prevent sunburn
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- 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
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Directions
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- apply liberally 15 minutes before sun exposure
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- use a water resistant sunscreen if swimming or sweating
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- reapply at least every 2 hours
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- children under 6 months: ask a doctor
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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.
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- wear long-sleeved shirts, pants, hats and sunglasses
- Other information
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Inactive ingredients
water, butyloctyl salicylate, caprylic/capric triglyceride, caprylyl methicone, polyglyceryl-10 pentastearate, glyceryl stearate, PEG-100 stearate, butylene glycol, pentylene glycol, behenyl alcohol, PEG-40 stearate, dimethicone, physalis angulata extract, algae extract, glycerin, iron oxides, phenoxyethanol, sodium stearoyl lactylate, polyhydroxystearic acid, mannitol, mica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, squalane, alumina, stearic acid, xanthan gum, calcium aluminium borosilicate, diatomaceous earth, sodium polyacrylate, disodium EDTA, synthetic fluorphlogopite, polysorbate 60, ethylhexylglycerin, zinc sulfate, silica, chlorphenesin, tetrahexyldecyl ascorbate, tin oxide, tocopherol
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
OBAGI SUN SHIELD TINT COOL SUNSCREEN BROAD SPECTRUM SPF 50
homosalate, octinoxate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8.5 g in 85 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.375 g in 85 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.677 g in 85 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.25 g in 85 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) 12-OXOOCTADECANOIC ACID (UNII: 31GL7GRO8F) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) DOCOSANOL (UNII: 9G1OE216XY) PEG-40 STEARATE (UNII: ECU18C66Q7) DIMETHICONE (UNII: 92RU3N3Y1O) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) FUCUS VESICULOSUS (UNII: 535G2ABX9M) GLYCERIN (UNII: PDC6A3C0OX) FERRIC OXIDE RED (UNII: 1K09F3G675) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MANNITOL (UNII: 3OWL53L36A) MICA (UNII: V8A1AW0880) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SQUALANE (UNII: GW89575KF9) ALUMINUM OXIDE (UNII: LMI26O6933) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYSORBATE 60 (UNII: CAL22UVI4M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ZINC SULFATE (UNII: 89DS0H96TB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) STANNIC OXIDE (UNII: KM7N50LOS6) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-150-10 1 in 1 CARTON 01/01/2016 1 85 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:62032-150-99 25 in 1 TRAY 01/01/2016 2 5 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 part352 01/01/2016 Labeler - OMP, INC. (790553353) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 MANUFACTURE(62032-150)